510(k) · Cleared
ClearedConsensus Unipolar Head, Cocr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hayes Medical, Inc. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Apr 1, 2003 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 34 later devices descend from it.
- Decided
- Apr 1, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 2 citing it directly.
- This deviceK030205 Consensus Unipolar Head, CocrHayes Medical, Inc. · 2003
- 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
- Descendant · 4 generations on · 7 of its ownK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- 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
- K172501iNSitu Total Hip SystemTheken Companies, LLC · 2017 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030205 | Consensus Unipolar Head, Cocr | Hayes Medical, Inc. | 2003 | — |
| +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 |
| +4 | K172501 | iNSitu Total Hip System | Theken Companies, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWL? 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 KWL device
- #1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (34)
See all 342 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?
- Of its descendants, K102399 (Consensus Orthopedics, Inc., 2010) has gone furthest, with 33 descendants of its own.
How does its category compare?
All KWL devicesKWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWL
32in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWL
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWL
29in 2025
MAUDE reports naming product code KWL, 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 | — | 36 | 11 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 2 | 21 |
| 2010 | 0 | — | 0 | 55 |
| 2011 | 2 | — | 0 | 51 |
| 2012 | 1 | — | 0 | 62 |
| 2013 | 0 | — | 0 | 89 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 1 | — | 1 | 223 |
| 2016 | 0 | — | 0 | 210 |
| 2017 | 0 | — | 2 | 347 |
| 2018 | 2 | — | 0 | 294 |
| 2019 | 1 | — | 0 | 415 |
| 2020 | 1 | — | 0 | 270 |
| 2021 | 0 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 99 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 1 | — | 0 | 143 |
| 2025 | 3 | 32 | 0 | 29 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The cobalt-chrome unipolar femoral head is design for use with the Consensus@ or UniSyn @ Hip Systems, and is not intended for substitution with components of other systems. The indications for use are: With Consensus@ System: A) Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck. B) Osteoarthrosis involving femoral and…
Read the full statement (289 words)
The cobalt-chrome unipolar femoral head is design for use with the Consensus@ or UniSyn @ Hip Systems, and is not intended for substitution with components of other systems. The indications for use are:
With Consensus@ System:
A) Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck.
B) Osteoarthrosis involving femoral and acetabular articular surfaces.
C) Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
D) Fracture or dislocation of the hip.
E) Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
With UniSyn System:
Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
Proximal femoral fractures.
Avascular necrosis of the femoral head.
Non-union of proximal femoral neck fractures.
Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple joint involvement, for whom restoration of joint mobility leads to an expectation of greater mobility and an improvement in the quality of life.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030205 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030205: Consensus Unipolar Head, Cocr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030205
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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