510(k) · Cleared
Cleared22 MM Cocr Head & Polyethlene Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stelkast Company · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on May 2, 1996 after a 107-day review. The FDA summary names no predicate by number. 29 later devices descend from it.
- Decided
- May 2, 1996
- Review
- 107 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 1 citing it directly.
- This deviceK960180 22 MM Cocr Head & Polyethlene LinerStelkast Company · 1996
- Descendant · cites it directly · 28 of its ownK073068 Accin Hip SystemAccelerated Innovation, LLC · 2008
- Descendant · 2 generations on · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- Descendant · 3 generations on · 16 of its ownK143407 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014
- Descendant · 3 generations on · 14 of its ownK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- Descendant · 4 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K073068Accin Hip SystemAccelerated Innovation, LLC · 2008 · cites it directly28descendants
- K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · 2 generations on25descendants
- K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014 · 3 generations on16descendants
- K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014 · 3 generations on14descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K960180 | 22 MM Cocr Head & Polyethlene Liner | Stelkast Company | 1996 | — |
| +1 | K073068 | Accin Hip System | Accelerated Innovation, LLC | 2008 | — |
| +2 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| +3 | K143407 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2014 | — |
| +3 | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
| +4 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073068 | Accin Hip System | 2008 | 28 |
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, K073068 (Accelerated Innovation, LLC, 2008) has gone furthest, with 28 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 | — |
https://510kreport.com/device/K960180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960180: 22 MM Cocr Head & Polyethlene Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960180
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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