510(k) · Cleared
ClearedTrabecular Metal Acetabular Revision System Cage
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 Aug 2, 2006 as substantially equivalent to K960678 (Intermedics Orthopedics, 1996) after a 92-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Aug 2, 2006
- Review
- 92 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953578 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK953578 Protek Acetabular Roof Reinforcement RingIntermedics Orthopedics · 1995
- 1 generation backK960678 Burch/Schneider Reinforcement CageIntermedics Orthopedics · 1996
- This deviceK061226 Trabecular Metal Acetabular Revision System CageZimmer, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK113296 ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or…Zimmer, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK253630 Mpact 3D Metal FoamMedacta International S.A. · 2026
- Descendant · 2 generations on · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025
Most influential descendants
Showing 4 of 4 · See all- K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc. · 2012 · cites it directly2descendants
- K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · cites it directly1descendant
- K253630Mpact 3D Metal FoamMedacta International S.A. · 2026 · cites it directly0descendants
- K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953578 | Protek Acetabular Roof Reinforcement Ring | Intermedics Orthopedics | 1995 | — |
| −1 | K960678 | Burch/Schneider Reinforcement Cage | Intermedics Orthopedics | 1996 | — |
| 0 (this device) | K061226 | Trabecular Metal Acetabular Revision System Cage | Zimmer, Inc. | 2006 | — |
| +1 | K113296 | ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented… | Zimmer, Inc. | 2012 | — |
| +1 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 | 1 |
| +1 | K253630 | Mpact 3D Metal Foam | Medacta International S.A. | 2026 | — |
| +2 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K960678 | Burch/Schneider Reinforcement CageSummary page 1…Porous, lincemented and Reference: 2! CFR § 888.3358 Predicate Device: BurchlzSchneiderTm Reinforcement Cage, K960678, cleared May 3, 1996, manufactured by Zimmer GmbH (former… | 1996 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113296 (Zimmer, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K960678.
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?
This device is intended for cemented use only as part of a layered construct and is indicated for patients with conditions of, but not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli. cystic acetabular roof: reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery, advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failed previous surgery, e.g., osteosynthesis.joint reconstruction. arthrodesis. herni-arthroplasty. or total hip replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061226: Trabecular Metal Acetabular Revision System Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061226
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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