Panels › Orthopedic › Product code KWZ · Class 2
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Regulation 888.3310
0510(k)s in 12 months (34 all time)
1recalls in 12 months (20 all time)
20recalls that name a 510(k)
Top companies in KWZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. ACETABULAR CUP UHMWPE
61-3258
ALL POLY CONSTRAINED INSERT 44MM
69-2244
ALL POLY CONSTRAINED INSERT 46MM
69-2246
ALL POLY CONSTRAINED INSERT 48MM
69-2248
ALL POLY CONSTRAINED INSERT 50M Open, Classified |
KWZ | K261624 |
| Jan 18, 2024 | Exactech, Inc. Exactech Novation Hip System, Catalog Numbers: 134-36-45 Open, Classified |
KWZ | K071676 |
| Aug 11, 2022 | Exactech, Inc. GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41
b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 1 Open, Classified |
KWZ | K071676 |
| Aug 11, 2022 | Exactech, Inc. GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05;
b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, RE Open, Classified |
KWZ | K040601 |
| Sep 21, 2018 | Encore Medical, Lp Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical,
REF: 495-00-065, 495-00-075, 495-00-085,
495-01-065, 495-01-075, 495-01-085 Terminated |
KWZ | K163497 |
| Jun 9, 2015 | Smith & Nephew, Inc. R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO.
Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to repla Terminated |
KWZ | K083566 |
| Jun 9, 2015 | Smith & Nephew, Inc. R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO,
Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to repl Terminated |
KWZ | K083566 |
| Jun 9, 2015 | Smith & Nephew, Inc. R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO.
Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to repla Terminated |
KWZ | K083566 |
| Jun 9, 2015 | Smith & Nephew, Inc. R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO.
Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to repla Terminated |
KWZ | K083566 |
| Jun 9, 2015 | Smith & Nephew, Inc. R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO.
Product Usage:
The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to repla Terminated |
KWZ | K083566 |
| Nov 20, 2012 | Zimmer, Inc. Trilogy II Constrained Liner
The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty. Terminated |
KWZ | K071718 |
| Sep 20, 2012 | DePuy Orthopaedics, Inc. S-Rom Total Hip System Poly Liner
Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch Terminated |
KWZ | K071117 |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339166, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | K083566 |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339164, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | K083566 |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339162, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | K083566 |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | K083566 |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339158, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | K083566 |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339156, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | K083566 |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339154, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | K083566 |
| Oct 18, 2010 | Smith & Nephew Inc R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.
Acetabular Liner Terminated |
KWZ | K083566 |
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