CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00— 510(k) K030265
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K030265 for CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00, Substantially Equivalent on 2003-03-04. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
Recent devices under product code JDI
view all- K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments
- K253434 — OSSTM Orthopedic Salvage System
- K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
- K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
- K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
More 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 JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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 K030265
K-number listed on FDA's recall record- Z-0843-2016 — CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures."
- Z-1120-2016 — Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400010 CPT 12/14 COCR SIZE 0 EXT 811400000 CPT 12/14 COCR SIZE 0 STD 811400110 CPT 12/14 COCR SIZE 1 EXT 811400100 CPT 12/14 COCR SIZE 1 STD 811400210 CPT 12/14 COCR SIZE 2 EXT 811400200 CPT 12/14 COCR SIZE 2 STD 811400230 CPT 12/14 COCR SIZE 2 XEX 811400310 CPT 12/14 COCR SIZE 3 EXT 811400300 CPT 12/14 COCR SIZE 3 STD 811400330 CPT 12/14 COCR SIZE 3 XEX 811400410 CPT 12/14 COCR SIZE 4 EXT 811400400 CPT 12/14 COCR SIZE 4 STD 811400430 CPT 12/14 COCR SIZE 4 XEX 811400510 CPT 12/14 COCR SIZE 5 EXT 811400500 CPT 12/14 COCR SIZE 5 STD 811400530 CPT 12/14 COCR SIZE 5 XEX For use in total or hemi hip arthroplasty
- Z-1032-2014 — CPT 12/14 COCR (various sizes)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030265.
Data sourced from openFDA. This site is unofficial and independent of the FDA.