510(k) · Cleared
Recalled · Class II · 2018Trabecular Metal Primary Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jun 30, 2005 as substantially equivalent to K964769 (Zimmer, Inc., 1997) after a 24-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 30, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 3 generations to K850055 (1985). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 2 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 1 generation backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- This deviceK051491 Trabecular Metal Primary Hip ProsthesisZimmer, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −2 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −1 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| 0 (this device) | K051491 | Trabecular Metal Primary Hip Prosthesis | Zimmer, Inc. | 2005 | — |
| +1 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 | 1 |
| +2 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K964769 | Versys Hip System--Fiber Metal Taper Hip ProsthesisSummary page 1…VerSys TM Hip System - Fiber Metal Taper Hip Prosthesis, manufactured by Zimmer, Inc., K964769, cleared February 13, 1997 Device Description: The TrabecularMetal Primary Hip Prosthesis is… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2018 | Class II | Z-0939-2018 | Labeling mix-ups | Two lots of hip implants are mislabeled. |
| Nov 16, 2011 | Not classified | Z-0366-2012 | Nonconforming Material/Component | Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been… |
| Aug 2, 2006 | Not classified | Z-1471-06 | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
| Aug 2, 2006 | Not classified | Z-1473-06 | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
| Aug 2, 2006 | Not classified | Z-1472-06 | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K200823 (Zimmer, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K964769.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected…
Read the full statement (133 words)
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051491: Trabecular Metal Primary Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051491
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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