510(k) · Cleared
ClearedConverge Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 14, 2001 after a 90-day review. The FDA summary names its predicate without a number. 247 later devices descend from it.
- Decided
- Nov 14, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
247 later devices descend from it, 1 citing it directly.
- This deviceK012739 Converge Acetabular SystemSulzer Orthopedics, Inc. · 2001
- Descendant · cites it directly · 246 of its ownK091508 Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular…Zimmer, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 144 of its ownK093846 Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010
- Descendant · 2 generations on · 143 of its ownK101229 Longevity IT Highly Crosslinked Polyethylene Elevated Liners…Zimmer, Inc. · 2010
- Descendant · 2 generations on · 137 of its ownK103662 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems…Zimmer, Inc. · 2011
- Descendant · 2 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
Showing 5 of 247 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 247 · See all- K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemZimmer, Inc. · 2009 · cites it directly246descendants
- K093846Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010 · 2 generations on144descendants
- K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…Zimmer, Inc. · 2010 · 2 generations on143descendants
- K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc. · 2011 · 2 generations on137descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 2 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012739 | Converge Acetabular System | Sulzer Orthopedics, Inc. | 2001 | — |
| +1 | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System | Zimmer, Inc. | 2009 | 3 |
| +2 | K093846 | Longevity IT Highly Crosslinked Polyethylene Elevated Liners | Zimmer, Inc. | 2010 | — |
| +2 | K101229 | Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum… | Zimmer, Inc. | 2010 | — |
| +2 | K103662 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT… | Zimmer, Inc. | 2011 | — |
| +2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 11 | 0 |
| 2013 | 13 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 8 | 0 |
| 2018 | 17 | 0 |
| 2019 | 25 | 0 |
| 2020 | 20 | 0 |
| 2021 | 13 | 0 |
| 2022 | 18 | 0 |
| 2023 | 18 | 0 |
| 2024 | 21 | 0 |
| 2025 | 26 | 0 |
| 2026 | 27 | 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? (5)
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 |
|---|---|---|---|
| * | — | Sulzer Orthopedics Inter-Op Acetabular System Named without a submission number | |
| * | — | Zimmer Trilogy Acetabular System Named without a submission number | |
| * | — | Stryker/Osteonics/Howmedica System 12 Acetabular System Named without a submission number | |
| * | — | Smith & Nephew Orthopaedics Reflection Acetabular System Named without a submission number | |
| * | — | DePuy Duraloc Acetabular System Named without a submission number |
What descends from it? (247)
See all 2471 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System | 2009 | 246 |
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?
- Of its descendants, K091508 (Zimmer, Inc., 2009) has gone furthest, with 246 descendants of its own.
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?
Components of the Converge Acetabular System are intended for use in total hip arthroplasty for treatment of the following:
1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
3. Revision of previously failed hip arthroplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012739 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012739: Converge 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/K012739
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026