Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System— 510(k) K150818
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K150818 for Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System, Substantially Equivalent on 2015-05-01. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code KTT
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Adverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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 K150818
K-number listed on FDA's recall record- Z-0326-2020 — Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 00118101032 00118101035 00118101037 00118101040 00118101042 00118101045 00118101047 00118101050 00118101052 00118101055 00118101057 00118101060 00118101522 00118101525 00118101527 00118101530 00118101532 00118101547 00118101552 00118101557 00118109006 00118109008 00118109010 00118109506 00118109510 00118113002 00118113003 00118113004 00118113005 00118113006 00118113008 00118113010 00118113012 00118113094 00118113502 00118113503 00118113504 00118113505 00118113506 00118113508 00118113510 00118113512 00118113514 00118113594 00118113595 00118114002 00118114003 00118114004 00118114005 00118114006 00118114008 00118114010 00118114012 00118114014 00118114094 00118114095 00118114502 00118114503 00118114504 00118114505 00118114506 00118114508 00118114510 00118114512 00118114514 00118114594 00118114595 00118115002 00118115003 00118115004 00118115005 00118115006 00118115008 00118115010 00118115012 00118115094 00119300520 00119300522 00119300525 00119300537 00119301020 00119301022 00119301025 00119301027 00119301030 00119301032 00119301035 00119301037 00119301040 00119301042 00119301045 00119301047 00119301050 00119301052 00119301057 00119301070 00119301520 00119301522 00119301525 00119301530 00119301532 00119301535 00119301537 00119301540 00119301542 00119301545 00119301547 00119301550 00119301552 00119301555 00119301557 00119301560 00119301562 00119301567 00119309008 00119309010 00119309012 00119309014 00119309506 00119309508 00119309510 00119309512 00119309514 00119309516 00119309522 00119313002 00119313003 00119313004 00119313005 00119313006 00119313008 00119313010 00119313012 00119313016 00119313094 00119313095 00119313096 00119313502 00119313503 00119313504 00119313505 00119313506 00119313508 00119313510 00119313512 00119313514 00119313516 00119313594 00119313595 00119313596 00119314002 00119314003 00119314004 00119314005 00119314006 00119314008 00119314010 00119314012 00119314018 00119314094 00119314095 00119314096 00119314502 00119314503 00119314504 00119314505 00119314506 00119314508 00119314510 00119314512 00119314514 00119314516 00119314520 00119314594 00119314595 00119314596 00119315003 00119315004 00119315005 00119315006 00119315008 00119315010 00119315012 00119315014 00119315016 00119315018 00119315020 00119315094 00119315095 00119315096 00119413004 00119413005 00119413006 00119413008 00119413504 00119413505 00119413506 00119413508 00119413594 00119413595 00119413596 00119414004 00119414005 00119414006 00119414008 00119414504 00119414505 00119414506 00119414508 00119415004 00119415005 00119415006 00119415008 00223200118 00223200128 00223200228 00223200301 00223200302 00223200303 00223200318 00223200418 00223200518 00223201113 00223202113 00223205018 00223205019 00223205020 00223205021 47223206000 47223206035 47223206055 47249134015 47249136015 47249140015 47249142015 47249144015 47249146015 47249148009 47249148010 47249148011 47249148012 47249148013 47249148014 47249148015 47249248009 47249248010 47249248011 47249248012 47249248013 47249248014 47249248109 47249248110 47249248111 47249248112 47249248113 47249248114 47349134009 47349134010 47349134011 47349134012 47349134013 47349134014 47349134015 47349136009 47349136010 47349136011 47349136012 47349136013 47349136014 47349136015 47349138009 47349138010 47349138011 47349138012 47349138013 47349138014 47349138015 47349140009 47349140010 47349140011 47349140012 47349140013 47349140014 47349140015 47349142009 47349142010 473491420
- Z-1682-2016 — VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
- Z-1118-2016 — Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47116202400 COMPRESSION SCREW 1-3/4IN 47116202100 COMPRESSION SCREW 1IN 47116202000 COMPRESSION SCREW 3/4IN Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
- Z-1129-2016 — Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114002 FREE-LOCK TUBE & SCP PLAT 118114003 FREE-LOCK TUBE & SCP PLAT 118114502 FREE-LOCK TUBE & SCP PLAT 118114503 FREE-LOCK TUBE & SCP PLAT 118115002 FREE-LOCK TUBE & SCP PLAT 118115003 FREE-LOCK TUBE & SCP PLAT Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
- Z-1139-2016 — Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301050 LAG SCR 12.7D X 115MM STA 119301052 LAG SCR 12.7D X 120MM STA 119301055 LAG SCR 12.7D X 125MM STA 119301057 LAG SCR 12.7D X 130MM STA 119301060 LAG SCR 12.7D X 135MM STA 119301062 LAG SCR 12.7D X 140MM STA 119301070 LAG SCR 12.7D X 155MM STA 119301020 LAG SCR 12.7D X 55MM STAN 119301022 LAG SCR 12.7D X 60MM STAN 119301025 LAG SCR 12.7D X 65MM STAN 119301027 LAG SCR 12.7D X 70MM STAN 119301030 LAG SCR 12.7D X 75MM STAN 119301032 LAG SCR 12.7D X 80MM STAN 119301035 LAG SCR 12.7D X 85MM STAN 119300537 LAG SCR 12.7D X 90MM SHOR 119301037 LAG SCR 12.7D X 90MM STAN 119301040 LAG SCR 12.7D X 95MM STAN 119301542 LAG SCR 15.8D X 100MM LAR 119301545 LAG SCR 15.8D X 105MM LAR 119301547 LAG SCR 15.8D X 110MM LAR 119301550 LAG SCR 15.8D X 115MM LAR 119301552 LAG SCR 15.8D X 120MM LAR 119301555 LAG SCR 15.8D X 125MM LAR 119301557 LAG SCR 15.8D X 130MM LAR 119301520 LAG SCR 15.8D X 55MM LARG 119301522 LAG SCR 15.8D X 60MM LARG 119301525 LAG SCR 15.8D X 65MM LARG 119301532 LAG SCR 15.8D X 80MM LARG 119301535 LAG SCR 15.8D X 85MM LARG 119301537 LAG SCR 15.8D X 90MM LARG Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
- Z-1163-2016 — Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 119413004 VERSA-FX II KEYLESS TUBE 119413005 VERSA-FX II KEYLESS TUBE 119413006 VERSA-FX II KEYLESS TUBE 119413008 VERSA-FX II KEYLESS TUBE 119413504 VERSA-FX II KEYLESS TUBE 119413505 VERSA-FX II KEYLESS TUBE 119413506 VERSA-FX II KEYLESS TUBE 119413508 VERSA-FX II KEYLESS TUBE 119414004 VERSA-FX II KEYLESS TUBE 119414005 VERSA-FX II KEYLESS TUBE 119414006 VERSA-FX II KEYLESS TUBE 119414008 VERSA-FX II KEYLESS TUBE 119414504 VERSA-FX II KEYLESS TUBE 119414506 VERSA-FX II KEYLESS TUBE 119414508 VERSA-FX II KEYLESS TUBE 119415004 VERSA-FX II KEYLESS TUBE 119415005 VERSA-FX II KEYLESS TUBE 119415006 VERSA-FX II KEYLESS TUBE 119415008 VERSA-FX II KEYLESS TUBE 119313094 VERSA-FX II SHORT TUBE PL 119313095 VERSA-FX II SHORT TUBE PL 119313096 VERSA-FX II SHORT TUBE PL 119313594 VERSA-FX II SHORT TUBE PL 119313595 VERSA-FX II SHORT TUBE PL 119313596 VERSA-FX II SHORT TUBE PL 119314094 VERSA-FX II SHORT TUBE PL 119314594 VERSA-FX II SHORT TUBE PL 119314595 VERSA-FX II SHORT TUBE PL 119315094 VERSA-FX II SHORT TUBE PL 119315095 VERSA-FX II SHORT TUBE PL 119313002 VERSA-FX II STD TUBE PLAT 119313003 VERSA-FX II STD TUBE PLAT 119313004 VERSA-FX II STD TUBE PLAT 119313005 VERSA-FX II STD TUBE PLAT 119313006 VERSA-FX II STD TUBE PLAT 119313008 VERSA-FX II STD TUBE PLAT 119313010 VERSA-FX II STD TUBE PLAT 119313012 VERSA-FX II STD TUBE PLAT 119313502 VERSA-FX II STD TUBE PLAT 119313503 VERSA-FX II STD TUBE PLAT 119313504 VERSA-FX II STD TUBE PLAT 119313505 VERSA-FX II STD TUBE PLAT 119313506 VERSA-FX II STD TUBE PLAT 119313508 VERSA-FX II STD TUBE PLAT 119313510 VERSA-FX II STD TUBE PLAT 119313512 VERSA-FX II STD TUBE PLAT 119314002 VERSA-FX II STD TUBE PLAT 119314003 VERSA-FX II STD TUBE PLAT 119314004 VERSA-FX II STD TUBE PLAT 119314005 VERSA-FX II STD TUBE PLAT 119314006 VERSA-FX II STD TUBE PLAT 119314502 VERSA-FX II STD TUBE PLAT 119314503 VERSA-FX II STD TUBE PLAT 119314504 VERSA-FX II STD TUBE PLAT 119314505 VERSA-FX II STD TUBE PLAT 119314506 VERSA-FX II STD TUBE PLAT 119314510 VERSA-FX II STD TUBE PLAT 119314512 VERSA-FX II STD TUBE PLAT 119315003 VERSA-FX II STD TUBE PLAT 119315004 VERSA-FX II STD TUBE PLAT 119315005 VERSA-FX II STD TUBE PLAT 119315006 VERSA-FX II STD TUBE PLAT 119315012 VERSA-FX II STD TUBE PLAT 119315014 VERSA-FX II STD TUBE PLAT 119315018 VERSA-FX II STD TUBE PLAT 119309008 VERSA-FX II SUPRACONDYLR 119309010 VERSA-FX II SUPRACONDYLR 119309012 VERSA-FX II SUPRACONDYLR 119309014 VERSA-FX II SUPRACONDYLR 119309506 VERSA-FX II SUPRACONDYLR 119309508 VERSA-FX II SUPRACONDYLR 119309510 VERSA-FX II SUPRACONDYLR 119309512 VERSA-FX II SUPRACONDYLR 119309514 VERSA-FX II SUPRACONDYLR 119309516 VERSA-FX II SUPRACONDYLR 119309522 VERSA-FX II SUPRACONDYLR Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150818.
Data sourced from openFDA. This site is unofficial and independent of the FDA.