510(k) · Cleared
Recalled · Class II · 2019Metasul Taper Liners, Metasul Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Nov 17, 2009 as substantially equivalent to K974728 (Sulzer Orthopedics, Inc., 1999) and 2 other predicates after a 139-day review. Its family tree reaches back 4 generations to 2001. It has been recalled 4 times.
- Decided
- Nov 17, 2009
- Review
- 139 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 4 generations to K004043 (2001). 16 ancestors in all, the oldest K883460 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK004043 Metal Transcend Articulation SystemWrightmedicaltechnologyinc · 2001
- 3 generations backK021349 Metal Transcend Articulation System (Larger Sizes)Wrightmedicaltechnologyinc · 2002
- 2 generations backK040627 Depuy Asr Modular Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2005 · Recalled
- 1 generation backK062426 Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc. · 2006
- This deviceK091973 Metasul Taper Liners, Metasul Femoral HeadsZimmer GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K004043 | Metal Transcend Articulation System | Wrightmedicaltechnologyinc | 2001 | — |
| −3 | K021349 | Metal Transcend Articulation System (Larger Sizes) | Wrightmedicaltechnologyinc | 2002 | — |
| −2 | K040627 | Depuy Asr Modular Acetabular Cup System | DePuy Orthopaedics, Inc. | 2005 | 55 |
| −1 | K062426 | Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners | DePuy Orthopaedics, Inc. | 2006 | — |
| 0 (this device) | K091973 | Metasul Taper Liners, Metasul Femoral Heads | Zimmer GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974728 | Inter-OP Metasul Acetabular SystemSummary page 1…cemented acetabular shell. Classification Reference: 21 CFR § 888.3330 Predicate Device: Inter-Op'TM Metasul Acetabular System (K974728), EpsilonlM Metasul Acetabular 32mm Insert/Fe… | 1999 |
| * | K033634 | Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedSummary page 1…l Acetabular System (K974728), EpsilonlM Metasul Acetabular 32mm Insert/Femoral Head (K033634), both manufactured by Zimmer, and Depuy Pinnacle Metal-on-Metal… | 2004 |
| * | K062426 | Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersSummary page 1…both manufactured by Zimmer, and Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners (K062426), manufactured by Depuy Orthopedics Device Description: The Meta… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0334-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 10, 2019 | Class II | Z-0335-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Jan 11, 2016 | Class II | Z-0850-2016 | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. |
| Aug 30, 2013 | Class II | Z-0071-2014 | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K974728.
How does its category compare?
All KWA devicesKWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KWA
4in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 2025
MAUDE reports naming product code KWA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 74 | 0 | 213 |
| 2008 | 9 | 57 | 13 | 762 |
| 2009 | 7 | 139 | 0 | 820 |
| 2010 | 6 | 167 | 84 | 3,348 |
| 2011 | 11 | 101 | 28 | 17,737 |
| 2012 | 4 | 76 | 21 | 24,601 |
| 2013 | 0 | — | 1 | 20,020 |
| 2014 | 0 | — | 0 | 16,494 |
| 2015 | 0 | — | 0 | 12,339 |
| 2016 | 0 | — | 1 | 7,872 |
| 2017 | 0 | — | 1 | 6,847 |
| 2018 | 0 | — | 1 | 6,388 |
| 2019 | 0 | — | 2 | 7,628 |
| 2020 | 0 | — | 1 | 4,538 |
| 2021 | 0 | — | 0 | 2,064 |
| 2022 | 0 | — | 0 | 1,617 |
| 2023 | 0 | — | 19 | 1,474 |
| 2024 | 0 | — | 0 | 1,168 |
| 2025 | 0 | — | 0 | 1,216 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication…
Read the full statement (123 words)
Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate.
Failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed hip arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
The system is intended for use either with or without bone cement in total hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091973: Metasul Taper Liners, Metasul Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091973
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026