ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY— 510(k) K112885
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K112885 for ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY, Substantially Equivalent on 2011-12-19. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code HWC
view allMore clearances from Zimmer, Inc.
view all- K260831 — Z1 Hip System
- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K112885
K-number listed on FDA's recall record- Z-1677-2016 — Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600 4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001 4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200 4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600 4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000 4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500 4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000 4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500 4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000 4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601 4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801 4.5 mm Cortical Screw Self-Tapping, 20 mm Length 47484502001 4.5 mm Cortical Screw Self-Tapping, 22 mm Length 47484502201 4.5 mm Cortical Screw SelfTapping, 24 mm Length 47484502401 4.5 mm Cortical Screw SelfTapping, 26 mm Length 47484502601 4.5 mm Cortical Screw SelfTapping, 28 mm Length 47484502801 4.5 mm Cortical Screw SelfTapping, 34 mm Length 47484503401 4.5 mm Cortical Screw SelfTapping, 38 mm Length 47484503801 4.5 mm Cortical Screw SelfTapping, 40 mm Length 47484504001 4.5 mm Cortical Screw SelfTapping, 42 mm Length 47484504201 4.5 mm Cortical Screw SelfTapping, 54 mm Length 47484505401 4.5 mm Cortical Screw Self-Tapping, 58 mm Length 47484505801 4.5 mm Cortical Screw SelfTapping, 64 mm Length 47484506401 4.5 mm Cortical Screw SelfTapping, 66 mm Length 47484506601 4.5 mm Cortical Screw SelfTapping, 68 mm Length 47484506801 4.5 mm Cortical Screw SelfTapping, 70 mm Length 47484507001 6.5 mm Cancellous Screw Fully Threaded, 45 mm Length 47486504500 6.5 mm Cancellous Screw Fully Threaded, 55 mm Length 47486505500 6.5 mm Cancellous Screw Fully Threaded, 60 mm Length 47486506000 6.5 mm Cancellous Screw, 32 mm Thread Length, 60 mm Length 47486506002 6.5 mm Cancellous Screw Fully Threaded, 65 mm Length 47486506500 6.5 mm Cancellous Screw, 32 mm Thread Length, 65 mm Length 47486506502 6.5 mm Cancellous Screw Fully Threaded, 70 mm Length 47486507000 6.5 mm Cancellous Screw, 16 mm Thread Length, 80 mm Length 47486508001 6.5 mm Cancellous Screw, 32 mm Thread Length, 80 mm Length 47486508002 6.5 mm Cancellous Screw, 32 mm Thread Length, 85 mm Length 47486508502
- Z-1102-2016 — Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X 32 CORT SCREW CRUCI 47482003403 2.0 X 34 CORT SCREW CRUCI 47482003603 2.0 X 36 CORT SCREW CRUCI 47482003803 2.0 X 38 CORT SCREW CRUCI 47482004003 2.0 X 40 CORT SCREW CRUCI 47482004203 2.0 X 42 CORT SCREW CRUCI 47482004403 2.0 X 44 CORT SCREW CRUCI 47482004603 2.0 X 46 CORT SCREW CRUCI 47482004803 2.0 X 48 CORT SCREW CRUCI 47482005003 2.0 X 50 CORT SCREW CRUCI 47482702000 2.7 X 20 CORT SCREW HEX Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
- Z-1108-2016 — Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
- Z-1111-2016 — Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
- Z-1116-2016 — Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14MM FUL 47248001641 CANC SCR 4.0MM X 16MM FUL 47248001840 CANC SCR 4.0MM X 18MM 47248001841 CANC SCR 4.0MM X 18MM FUL 47248002041 CANC SCR 4.0MM X 20MM FUL 47248002441 CANC SCR 4.0MM X 24MM FUL 47248003641 CANC SCR 4.0MM X 36MM FUL Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
- Z-2244-2014 — Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
- Z-2245-2014 — Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
- Z-2246-2014 — 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
- Z-2247-2014 — 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
- Z-2248-2014 — 6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
- Z-2249-2014 — 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
- Z-2250-2014 — 4.5 mm Malleolar Screw Sterile zimmer
- Z-2251-2014 — 4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer
- Z-1040-2014 — PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM CORT SCR X 10MM 3.5MM CORT SCR X 12MM 3.5MM CORT SCR X 14MM 3.5MM CORT SCR X 16MM 3.5MM CORT SCR X 18MM 3.5MM CORT SCR X 20MM 3.5MM CORT SCR X 22MM 3.5MM CORT SCR X 24MM 3.5MM CORT SCR X 26MM 3.5MM CORT SCR X 28MM 3.5MM CORT SCR X 30MM 3.5MM CORT SCR X 32MM 3.5MM CORT SCR X 34MM 3.5MM CORT SCR X 36MM 3.5MM CORT SCR X 38MM 3.5MM CORT SCR X 40MM 3.5MM CORT SCR X 42MM 3.5MM CORT SCR X 44MM 3.5MM CORT SCR X 46MM 3.5MM CORT SCR X 48MM 3.5MM CORT SCR X 50MM 3.5MM CORT SCR X 52MM 3.5MM CORT SCR X 54MM 3.5MM CORT SCR X 56MM 3.5MM CORT SCR X 58MM 3.5MM CORT SCR X 60MM 3.5MM CORT SCR X 65MM 3.5MM CORT SCR X 70MM 3.5MM CORT SCR X 75MM 3.5MM CORT SCR X 80MM 3.5MM CORT SCR X 85MM 3.5MM CORT SCR X 90MM 3.5MM CORT SCR X 100MM 3.5MM CORT SCR X 105MM 3.5MM CORT SCR X 110MM CANC SCR 4.0MM X 10MM CANC SCR 4.0MM X 10MM FUL CANC SCR 4.0MM X 12MM CANC SCR 4.0MM X 12MM FUL CANC SCR 4.0MM X 14MM CANC SCR 4.0MM X 14MM FUL CANC SCR 4.0MM X 16MM CANC SCR 4.0MM X 16MM FUL CANC SCR 4.0MM X 18MM CANC SCR 4.0MM X 18MM FUL CANC SCR 4.0MM X 20MM CANC SCR 4.0MM X 20MM FUL CANC SCR 4.0MM X 22MM CANC SCR 4.0MM X 22MM FUL CANC SCR 4.0MM X 24MM CANC SCR 4.0MM X 24MM FUL CANC SCR 4.0MM X 26MM CANC SCR 4.0MM X 26MM FUL CANC SCR 4.0MM X 28MM CANC SCR 4.0MM X 28MM FUL CANC SCR 4.0MM X 30MM CANC SCR 4.0MM X 30MM FUL CANC SCR 4.0MM X 32MM CANC SCR 4.0MM X 32MM FUL CANC SCR 4.0MM X 34MM CANC SCR 4.0MM X 34MM FUL CANC SCR 4.0MM X 36MM CANC SCR 4.0MM X 36MM FUL CANC SCR 4.0MM X 38MM CANC SCR 4.0MM X 38MM FUL CANC SCR 4.0MM X 40MM CANC SCR 4.0MM X 40MM FUL
- Z-1042-2014 — 1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 CORT SCREW CRUCI 2.0 X 30 CORT SCREW CRUCI 2.0 X 32 CORT SCREW CRUCI 2.0 X 34 CORT SCREW CRUCI 2.0 X 36 CORT SCREW CRUCI 2.0 X 38 CORT SCREW CRUCI 2.0 X 40 CORT SCREW CRUCI 2.0 X 42 CORT SCREW CRUCI 2.0 X 44 CORT SCREW CRUCI 2.0 X 46 CORT SCREW CRUCI 2.0 X 48 CORT SCREW CRUCI 2.0 X 50 CORT SCREW CRUCI 2.7MM CORT. SCREW 6MM, ST 2.7MM CORT. SCREW 7MM, ST 2.7MM CORT. SCREW 8MM, ST 2.7MM CORT. SCREW 9MM, ST 2.7MM CORT. SCREW 10MM, S 2.7MM CORT. SCREW 12MM, S 2.7MM CORT. SCREW 14MM, S 2.7MM CORT. SCREW 16MM, S 2.7MM CORT. SCREW 18MM, S 2.7MM CORT. SCREW 20MM, S 2.7MM CORT. SCREW 22MM, S 2.7MM CORT. SCREW 24MM, S 2.7MM CORT. SCREW 26MM, S 2.7MM CORT. SCREW 28MM, S 2.7MM CORT. SCREW 30MM, S 2.7MM CORT. SCREW 32MM, S 2.7MM CORT. SCREW 34MM, S 2.7MM CORT. SCREW 36MM, S 2.7MM CORT. SCREW 38MM, S 2.7MM CORT. SCREW 40MM, S 2.7MM CORT. SCREW 42MM, S 2.7MM CORT. SCREW 44MM, S 2.7MM CORT. SCREW 45MM, S 2.7MM CORT. SCREW 46MM, S 2.7MM CORT. SCREW 48MM, S 2.7MM CORT. SCREW 50MM, S 2.7X52 CORT SCREW/SELFTAP 2.7X54 CORT SCREW/SELFTAP 2.7X55 CORT SCREW/SELFTAP 2.7X56 CORT SCREW/SELFTAP 2.7X58 CORT SCREW/SELFTAP 2.7X60 CORT SCREW/SELFTAP 2.7X65 CORT SCREW/SELFTAP 2.7X70 CORT SCREW/SELFTAP 3.5MM CORT. SCREW 10MM LN 3.5MM CORT. SCREW 12MM LN 3.5X14 CORT SCREW 3.5MM CORT. SCREW 14MM LN 3.5X16 CORT SCREW 3.5MM CORT. SCREW 16MM LN 3.5 X 16 SHAFT SCREW 3.5X18 CORT SCREW 3.5MM CORT. SCREW 18MM LN 3.5 X 18 SHAFT SCREW 3.5MM CORT. SCREW 20MM LN 3.5 X 20 SHAFT SCREW 3.5MM CORT. SCREW 22MM LN 3.5 X 22 SHAFT SCREW 3.5MM CORT. SCREW 24MM LN 3.5 X 24 SHAFT SCREW 3.5MM CORT. SCREW 26MM LN 3.5 X 26 SHAFT SCREW 3.5MM CORT. SCREW 28MM LN 3.5 X 28 SHAFT SCREW 3.5MM CORT. SCREW 30MM LN 3.5 X 30 SHAFT SCREW 3.5MM CORT. SCREW 32MM LN 3.5 X 32 SHAFT SCREW 3.5MM CORT. SCREW 34MM LN 3.5 X 34 SHAFT SCREW 3.5MM CORT. SCREW 36MM LN 3.5 X 36 SHAFT SCREW 3.5MM CORT. SCREW 38MM LN 3.5 X 38 SHAFT SCREW 3.5MM CORT. SCREW 40MM LN 3.5 X 40 SHAFT SCREW 3.5MM CORT. SCREW 45MM LN 3.5MM CORT. SCREW 50MM LN 3.5 X 50 SHAFT SCREW 3.5MM CORT. SCREW 55MM LN 3.5MM CORT. SCREW 60MM LN 3.5MM CORT. SCREW 65MM LN 3.5MM CORT. SCREW 70MM LN 3.5MM CORT. SCREW 75MM LN 3.5MM CORT. SCREW 80MM LN 3.5X85 CORT SCREW 3.5X90 CORT SCREW 3.5X95 CORT SCREW 3.5X100 CORT SCREW 3.5X105 CORT SCREW 3.5X110 CORT SCREW 3.5X115 CORT SCREW 3.5X120 CORT SCREW 3.5X125 CORT SCREW 3.5X130 CORT SCREW 3.5X135 CORT SCREW 3.5X140 CORT SCREW 3.5X145 CORT SCREW 3.5X150 CORT SCREW 4.0 X 10 CANCELL. SCREW 4.0 X 10 PART THD CANC SC 4.0 X 12 CANCELL. SCREW 4.0 X 12 PART THD CANC SC 4.0 X 14 CANCELL. SCREW 4.0 X 14 PART THD CANC SC 4.0 X 16 CANCELL. SCREW 4.0 X 16 PART THD CANC SC 4.0 X 18 CANCELL. SCREW 4.0 X 18 PART THD CANC SC 4.0 X 20 CANCELL. SCREW 4.0 X 20 PART THD CANC SC 4.0 X 22 CANCELL. SCREW 4.0 X 22 PART THD CANC SC 4.0 X 24 CANCELL. SCREW 4.0 X 24 PART THD CANC SC 4.0 X 26 CANCELL. SCREW 4.0 X 26 PART THD CANC SC 4.0 X 28 CANCELL. SCREW 4.0 X 28 PART THD CANC SC 4.0 X 30 CANCELL. SCREW 4.0 X 30 PART THD CANC SC 4.0 X 32 CANCELL. SCREW 4.0 X 34 CANCELL. SCREW 4.0 X 35 PART THD CANC SC 4.0 X 36 CANCELL. SCREW 4.0 X 40 CANCELL. SCREW 4.0 X 40 PART THD CANC SC 4.0 X 45 CANCELL. SCREW 4.0 X 45 PART THD CANC SC 4.0 X 50 CANCELL. SCREW 4.0 X 50 PART THD CANC SC 4.0 X 55 CANCELL. SCREW 4.0 X 55 PART THD CANC SC 4.0 X 60 CANCELL. SCREW 4.0 X 60 PART THD CANC SC 4.0 X 65 CANCELL. SCREW 4.0
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112885.
Data sourced from openFDA. This site is unofficial and independent of the FDA.