510(k) · Cleared
Cleared36MM Cocr Femoral Head and 36MM Acetabular Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hayes Medical, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Jan 31, 2007 as substantially equivalent to K922561 (U.S. Medical Products, Inc., 1993) and 3 other predicates after a 26-day review. Its family tree reaches back 3 generations to 1981. 38 later devices descend from it.
- Decided
- Jan 31, 2007
- Review
- 26 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K810258 (1981). 10 ancestors in all. 38 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 2 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 1 generation backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- This deviceK070061 36MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc. · 2007
- Descendant · cites it directly · 35 of its ownK100933 Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010
- Descendant · cites it directly · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- Descendant · 2 generations on · 20 of its ownK121935 Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012
- Descendant · 3 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- Descendant · 4 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010 · cites it directly35descendants
- K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · cites it directly33descendants
- K121935Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012 · 2 generations on20descendants
- K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 3 generations on19descendants
- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −2 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −1 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| 0 (this device) | K070061 | 36MM Cocr Femoral Head and 36MM Acetabular Insert | Hayes Medical, Inc. | 2007 | — |
| +1 | K100933 | Consensus CS2 Plus Acetabular Insert | Consensus Orthopedics, Inc. | 2010 | — |
| +1 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
| +2 | K121935 | Taperset Hip Small Stems | Consensus Orthopedics, Inc. | 2012 | — |
| +3 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| +4 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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: Class 1I Device Classification Panel: Orthopaedic Snbstantially Equivalent To: Hayes Medical Consensus Hip System (K922561) Hayes Medical Crosslinked UHMWPE Insert (K02 1466)… | 1993 |
| * | K021466 | Consensus Acetabular Insert, Cross-Linked PolyethyleneSummary page 1…tantially Equivalent To: Hayes Medical Consensus Hip System (K922561) Hayes Medical Crosslinked UHMWPE Insert (K02 1466) DePuy 36mom LIHMWPE highly crosslinked liner (K994415)… | 2002 |
| * | K994415 | Marathon Cross-Linked Polyethylene Acetabular Cup LinersSummary page 1…Hayes Medical Crosslinked UHMWPE Insert (K02 1466) DePuy 36mom LIHMWPE highly crosslinked liner (K994415) Biomet Orthopedics, Inc., RingLoc® 36mm femoral head and liner… | 2000 |
| * | K032396 | Ringloc 36MM Line and Modular Femoral HeadsSummary page 1…d liner (K994415) Biomet Orthopedics, Inc., RingLoc® 36mm femoral head and liner (K032396) Intended Use: Indications for use of the Cousensusirm Hip System or UNISYNTm H1ip System A) Significantly impaired joints result… | 2003 |
What descends from it? (38)
See all 387 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100933 | Consensus CS2 Plus Acetabular Insert | 2010 | 35 |
| K102399 | Consensus Taperset Hip System | 2010 | 33 |
| K122512 | CS2 Hip System | 2012 | 3 |
| K081973 | Metha Short Stem Hip System; Modular Hip System; Excia Hip System | 2008 | 2 |
| K121636 | Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert | 2012 | 1 |
| K130652 | Vitalite E Cross-Linked Polyethylene Acetabular Insert | 2013 | 0 |
| K110542 | Consensus Biolox Delta Ceramic Femoral Head | 2011 | 0 |
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 26 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K100933 (Consensus Orthopedics, Inc., 2010) has gone furthest, with 35 descendants of its own.
- 10 other devices also cite its predicate K922561.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, 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 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indications for use with the CONSENSUS® Hip System or UNISYN TM Hip Ssytem 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…
Read the full statement (122 words)
Indications for use with the CONSENSUS® Hip System or UNISYN TM Hip Ssytem
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
Acetabular components are indicated for cemented and cementless use.
Consensus femoral stems are indicated for cemented and cementless use.
UniSyn femoral stems are indicated for cementless use only.
HA coated implants are indicated for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070061
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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