510(k) · Cleared
ClearedZimmer Trabecular Metal Modular Acetabular System
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 Apr 28, 2010 as substantially equivalent to K021891 (Zimmer, Inc., 2002) and 1 other predicate after a 161-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Apr 28, 2010
- Review
- 161 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P960047 (1997). 8 ancestors in all, the oldest K934765 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- 3 generations backK021661 Ringloc Constrained LinersBiomet Orthopedics, Inc. · 2002
- 2 generations backK030923 Epsilon Durasul Constrained Acetabular LinerCenterpulse Orthopedics, Inc. · 2003
- 1 generation backK071718 Trilogy Longevity Constrained LinerZimmer, Inc. · 2007 · Recalled
- This deviceK093561 Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| −3 | K021661 | Ringloc Constrained Liners | Biomet Orthopedics, Inc. | 2002 | — |
| −2 | K030923 | Epsilon Durasul Constrained Acetabular Liner | Centerpulse Orthopedics, Inc. | 2003 | — |
| −1 | K071718 | Trilogy Longevity Constrained Liner | Zimmer, Inc. | 2007 | 1 |
| 0 (this device) | K093561 | Zimmer Trabecular Metal Modular Acetabular System | Zimmer, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 24.3 · 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? (2)
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 |
|---|---|---|---|
| * | K021891 | Zimmer Trabecular Metal Modular Acetabular SystemSummary page 2…emented prosthesis Predicate Device: Zimmer TrabecularMetalTM Modular Acetabular System, manufactured by Zimmer, Inc. K021891, cleared September 05, 2002. Trilogy®Longevity® Constrained… | 2002 |
| * | K071718 | Trilogy Longevity Constrained LinerSummary page 2…cleared September 05, 2002. Trilogy®Longevity® Constrained Liner, manufactured by Zimmer, Inx. K071718, cleared July 13, 2007. Device Description: The Zimmer TrabecularMetal Modular A… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K021891.
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. 2010, this device’s year, is highlighted.
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?
The TrabecularMetal Modular Acetabular System when used with a Trilogy®Neutral, Elevated, Offset or Oblique Liner is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NtDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant- The…
Read the full statement (135 words)
The TrabecularMetal Modular Acetabular System when used with a Trilogy®Neutral, Elevated, Offset or Oblique Liner is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NtDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant-
The Trabecular Metal Modular Acetabular System when used with a Trilogy Longevity®) Constrained Liner is indicated for primary or revision total hip arthorplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.
This device is intended for either cemented or noncemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093561: Zimmer Trabecular Metal Modular Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093561
Report an extraction error
Are you the manufacturer?
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