510(k) · Cleared
ClearedConsensus Acetabular Shell System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hayes Medical, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 28, 2006 as substantially equivalent to K922561 (U.S. Medical Products, Inc., 1993) and 4 other predicates after a 49-day review. Its family tree reaches back 5 generations to 1993. 69 later devices descend from it.
- Decided
- Apr 28, 2006
- Review
- 49 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K930712 (1993). 14 ancestors in all, the oldest K922561 (1993). 69 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 4 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 2 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 1 generation backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
- This deviceK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
- Descendant · cites it directly · 53 of its ownK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- Descendant · cites it directly · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- Descendant · cites it directly · 21 of its ownK141043 CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc. · 2014
- Descendant · 2 generations on · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- Descendant · 3 generations on · 20 of its ownK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012 · cites it directly53descendants
- K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · cites it directly33descendants
- K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc. · 2014 · cites it directly21descendants
- K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012 · 2 generations on21descendants
- K131237Pipeline Total Hip SystemPipeline Orthopedics · 2013 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −4 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −2 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K031110 | Apex Modular Acetabular Cup | Apex Surgical, LLC | 2003 | — |
| 0 (this device) | K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | 2006 | — |
| +1 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| +1 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
| +1 | K141043 | CS2 Multi-Hole Acetabular Shell | Consensus Orthopedics, Inc. | 2014 | — |
| +2 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| +3 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 9 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K922561 | Consensus (TM) Total Hip SystemSummary page 1…Class II Device Classification Panel: Orthopaedic Substantially Equivalent To: Hayes Medical, Consensus Acetabular Shell (K922561) Wright Medical, Lineage Cup (K002149)… | 1993 |
| * | K002149 | Lineage Acetabular SystemSummary page 1…ubstantially Equivalent To: Hayes Medical, Consensus Acetabular Shell (K922561) Wright Medical, Lineage Cup (K002149) Apex Surgical, Modular Acetabular Cup (K031110)… | 2000 |
| * | K031110 | Apex Modular Acetabular CupSummary page 1…1) Wright Medical, Lineage Cup (K002149) Apex Surgical, Modular Acetabular Cup (K031110) Orthopaedic Source, Avalon Acetabular Cup (K022711)… | 2003 |
| * | K022711 | Modification to Avalon Cup SystemSummary page 1…Apex Surgical, Modular Acetabular Cup (K031110) Orthopaedic Source, Avalon Acetabular Cup (K022711) Encore, Foundation Porous Acetabular System (K974095) Intended Use: Indicated for u… | 2002 |
| * | K974095 | Foundation Porous Coated Flared Rim ShellSummary page 1…Orthopaedic Source, Avalon Acetabular Cup (K022711) Encore, Foundation Porous Acetabular System (K974095) Intended Use: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skelet… | 1998 |
What descends from it? (69)
See all 696 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 13 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K112802 (Pipeline Orthopedics, 2012) has gone furthest, with 53 descendants of its own.
- 10 other devices also cite its predicate K922561.
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: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C. Proximal femoral fractures D. Avascular necrosis of the femoral head E. Non-union of proximal femoral…
Read the full statement (97 words)
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:
A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic
arthritis.
B. Revision of failed femoral head replacement, cup arthroplasty or other hip
procedures.
C. Proximal femoral fractures
D. Avascular necrosis of the femoral head
E. Non-union of proximal femoral neck fractures
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa
magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic
and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion
and structural abnormalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060635 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060635: Consensus Acetabular Shell System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060635
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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