Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
Orthopedic · 21 CFR 888.3358
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
Recent MDR events
673 adverse event reports on file
- DJO SURGICALJul 15, 2026InjuryEncore Medical L.p.1644408-2026-01377
- DJO SURGICALJul 7, 2026InjuryEncore Medical L.p1644408-2026-01292
- DJO SURGICALJun 10, 2026InjuryEncore Medical Lp1644408-2026-01145
- CUSTOM-MADE PARTIAL PELVIC REPLACEMENTJun 9, 2026InjuryWaldemar Link Gmbh & Co. Kg3006721341-2026-00012
- VIVACIT-E DM BEARING 28X44MMJun 1, 2026InjuryZimmer Biomet, Inc.0001822565-2026-01725
- DJO SURGICALMay 27, 2026InjuryEncore Medical L.p1644408-2026-00989
- VITELENE INSERT H 36MM SYM.May 22, 2026InjuryAesculap Ag9610612-2026-00115
- DJO SURGICAMay 12, 2026InjuryEncore Medical L.p1644408-2026-00872
- DJO SURGICALApr 13, 2026InjuryEncore Medical Lp1644408-2026-00704
- DJO SURGICALApr 7, 2026InjuryEncore Medical Lp1644408-2026-00560
Event type breakdown
Recalls
2 recall events for this product code
- Conformis, Inc.Open, ClassifiedAug 16, 2023
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
30mm screws were labeled as 25mm screws.
Z-2405-2023 · View FDA record ↗ - Stelkast CoTerminatedApr 7, 2013
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52.
Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.
Z-1066-2013 · View FDA record ↗
Registered firms
414 firms currently registered for this product code
Zimmer Biomet Canada Dfe
Mississauga Ontario, CA
Ceramtec Gmbh Medical Products Division
PLOCHINGEN Baden-Wurttemberg, DE
Orthoplastics Ltd
Bacup Lancashire, GB
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Zimmer Gmbh
WINTERTHUR Zurich, CH
Lincotek Bologna S.r.l.
Cadriano di Granarolo, Bologna, IT
Isomedix Operations, Inc.
Libertyville, IL, US
Biomet Global Supply Chain Center B.v.
Hazeldonk Noord-Brabant, NL
Zimmer Biomet G.k.
Hiratsuka Kanagawa, JP
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Ppd Meditech, Div. Of Industries Ppd Inc.
Waterville Quebec, CA
Zhejiang Biomet Medical Products Co., Ltd.
Jinhua Zhejiang, CN
Zimmer Biomet Korea Ltd.
Seoul, KR
Culver Tool & Engineering
Plymouth, IN, US
T & L Sharpening, Inc.
Indiana Beach, IN, US
Biomet, Inc.
WARSAW, IN, US
Isomedix Operations Inc
GROVEPORT, OH, US
Harwood Design, Inc.
Bristol, PA, US
510(k) clearances
20 clearances for this product code
- Microport Orthopedics, Inc.Aug 20, 2021
K202705 · Prime and DYNASTY® Additive Manufacturing Shells
- Kyocera Medical Technologies, Inc.Apr 2, 2021
K203472 · KMTI Hip Replacement System
- Kyocera Medical Technologies, Inc.Jul 16, 2020
K201660 · KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
- Kyocera Medical Technologies, Inc.Mar 11, 2020
K200328 · Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
- Encore Medical L.P.Dec 13, 2017
K172651 · FMP Extended Liners
- Renovis Surgical TechnologiesNov 16, 2017
K171543 · Renovis Surgical Hip Replacement System
- Total Joint Orthopedics, Inc.Oct 27, 2017
K173104 · Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
- Renovis Surgical Technologies, Inc.May 11, 2015
K143647 · Renovis Surgical Hip Replacement System