510(k) · Cleared
ClearedOpteon Unipolar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Mar 27, 1996 as substantially equivalent to K881288 (Orthopedic Systems, Inc., 1988) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 1988. 121 later devices descend from it.
- Decided
- Mar 27, 1996
- Review
- 49 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881288 (1988). 2 ancestors in all. 121 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK881288 Corin Modular Moore StemOrthopedic Systems, Inc. · 1988
- This deviceK960538 Opteon UnipolarExactech, Inc. · 1996
- Descendant · cites it directly · 117 of its ownK984028 The New Bio-Moore Endo HeadsBiomet, Inc. · 1999
- Descendant · 2 generations on · 116 of its ownK042037 M2A Magnum SystemBiomet, Inc. · 2004
- Descendant · 3 generations on · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
- Descendant · 4 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- Descendant · 5 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
Showing 5 of 121 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 121 · See all- K984028The New Bio-Moore Endo HeadsBiomet, Inc. · 1999 · cites it directly117descendants
- K042037M2A Magnum SystemBiomet, Inc. · 2004 · 2 generations on116descendants
- K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · 3 generations on74descendants
- K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 4 generations on73descendants
- K123392Avenir Muller StemZimmer GmbH · 2013 · 5 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881288 | Corin Modular Moore Stem | Orthopedic Systems, Inc. | 1988 | — |
| 0 (this device) | K960538 | Opteon Unipolar | Exactech, Inc. | 1996 | — |
| +1 | K984028 | The New Bio-Moore Endo Heads | Biomet, Inc. | 1999 | — |
| +2 | K042037 | M2A Magnum System | Biomet, Inc. | 2004 | — |
| +3 | K053536 | Durom Acetabular Component and Metasul LDH Large Diameter Heads | Zimmer GmbH | 2006 | 13 |
| +4 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| +5 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 12 | 0 |
| 2021 | 8 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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 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? (2)
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 |
|---|---|---|---|
| * | K881288 | Corin Modular Moore StemSummary page 1…ave been determined to be equivalent to devices on the market prior to May 28, 1976. These predicates include, but are not limited to: . Corin® Unipolar Endoprosthesis #K881288 . Howmedica Unitrax® Unipolar System #K902365 Exactech, Inc. has supplied advertisements, brochures and/or catalog information f… | 1988 |
| * | K902365 | Modular Unipolar SystemSummary page 1…s on the market prior to May 28, 1976. These predicates include, but are not limited to: . Corin® Unipolar Endoprosthesis #K881288 . Howmedica Unitrax® Unipolar System #K902365 Exactech, Inc. has supplied advertisements, brochures and/or catalog information from these companies to the FDA as evidence of… | 1991 |
What descends from it? (121)
See all 1212 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K984028 (Biomet, Inc., 1999) has gone furthest, with 117 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 OPTEON Unipolar Endoprosthesis is for use with a modular femoral stem when hemiarthroplasty is indicated. The change to a total hip replacement can then be accomplished in the future without removing the femoral stem.
The OPTEON Unipolar is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
It is also indicated for use in replacement of the femoral head following femoral neck fracture.
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/K960538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960538: Opteon Unipolar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960538
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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