510(k) · Cleared
ClearedLineage Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Aug 31, 2000 after a 45-day review. The FDA summary names no predicate by number. 244 later devices descend from it.
- Decided
- Aug 31, 2000
- Review
- 45 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
244 later devices descend from it, 11 citing it directly.
- This deviceK002149 Lineage Acetabular SystemWrightmedicaltechnologyinc · 2000
- Descendant · cites it directly · 217 of its ownK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- Descendant · 2 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · 3 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · cites it directly · 69 of its ownK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
- Descendant · 4 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
Showing 5 of 244 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 244 · See all- K031110Apex Modular Acetabular CupApex Surgical, LLC · 2003 · cites it directly217descendants
- K093472Trinity Acetabular SystemCorin USA · 2010 · 2 generations on117descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 3 generations on109descendants
- K060635Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006 · cites it directly69descendants
- K111911Corin Optimom Modular HeadCorin USA · 2011 · 4 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002149 | Lineage Acetabular System | Wrightmedicaltechnologyinc | 2000 | — |
| +1 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| +2 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +3 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +1 | K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | 2006 | — |
| +4 | K111911 | Corin Optimom Modular Head | Corin USA | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 15 | 0 |
| 2013 | 19 | 0 |
| 2014 | 10 | 0 |
| 2015 | 11 | 0 |
| 2016 | 10 | 0 |
| 2017 | 14 | 0 |
| 2018 | 16 | 0 |
| 2019 | 17 | 0 |
| 2020 | 13 | 0 |
| 2021 | 16 | 0 |
| 2022 | 18 | 0 |
| 2023 | 18 | 0 |
| 2024 | 12 | 0 |
| 2025 | 21 | 0 |
| 2026 | 15 | 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?
The FDA summary names no predicate by number.
What descends from it? (244)
See all 24411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031110 | Apex Modular Acetabular Cup | 2003 | 217 |
| K060635 | Consensus Acetabular Shell System | 2006 | 69 |
| K170444 | PROCOTYL® PRIME Acetabular Cup System | 2017 | 16 |
| K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | 2017 | 10 |
| K140043 | Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head | 2014 | 10 |
| K142119 | Procotyl L-O Acetabular System | 2015 | 9 |
| K161520 | ELEOS Limb Salvage System | 2016 | 6 |
| K132158 | Novohip Total Hip System | 2014 | 6 |
| K140701 | Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug | 2014 | 2 |
| K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | 2018 | 1 |
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, K031110 (Apex Surgical, LLC, 2003) has gone furthest, with 217 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?
Indicated for. use in total hip arthroplasty. -for reduction or relief of pain and/or improved hip function.in skeletally mature patients with the following conditions:
1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2) inflammatory degenerative joint disease such as rheumatoid arthritis;
3) correction of functional deformity;
4) revision procedures where other treatments or devices have failed; and,
5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
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/K002149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002149: Lineage Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002149
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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