510(k) · Cleared
ClearedFoundation Unipolar Femoral Head with Modular Neck Length Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Dec 18, 1997 after an 86-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Dec 18, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK973614 Foundation Unipolar Femoral Head with Modular Neck Length SleevesEncore Orthopedics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK990309 Plus Fracture Head ProsthesisPlus Orthopedics · 1999
- Descendant · 2 generations on · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973614 | Foundation Unipolar Femoral Head with Modular Neck Length Sleeves | Encore Orthopedics, Inc. | 1997 | — |
| +1 | K990309 | Plus Fracture Head Prosthesis | Plus Orthopedics | 1999 | — |
| +2 | K123598 | Smith & Nephew, Inc. Hip System Instrumentation | Smith & Nephew, Inc. | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2013 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990309 | Plus Fracture Head Prosthesis | 1999 | 1 |
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, K990309 (Plus Orthopedics, 1999) has gone furthest, with 1 descendant 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 Foundation® Unipolar femoral head is intended for treatment of patients who are candidates for hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis of femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the srugeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with any stem that has the appropriate size head. This submission includes the unipolar femoral head with a modular neck length sleeve.
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/K973614 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973614: Foundation Unipolar Femoral Head with Modular Neck Length Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973614
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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