510(k) · Cleared
ClearedBio-Fit Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richards Medical Co., Inc. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Cleared on Feb 27, 1986 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Feb 27, 1986
- Review
- 90 days
- Class
- Class II
- Product code
- KWL
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK854791 Bio-Fit Hip SystemRichards Medical Co., Inc. · 1986
- Descendant · cites it directly · 11 of its ownK935921 Zirconia Ceramic Femoral HeadSmith & Nephew Richards, Inc. · 1994
- Descendant · 2 generations on · 10 of its ownK965002 Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and…Encore Orthopedics, Inc. · 1997
- Descendant · 3 generations on · 9 of its ownK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
- Descendant · 4 generations on · 7 of its ownK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
- Descendant · 5 generations on · 4 of its ownK101451 Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K935921Zirconia Ceramic Femoral HeadSmith & Nephew Richards, Inc. · 1994 · cites it directly11descendants
- K965002Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the…Encore Orthopedics, Inc. · 1997 · 2 generations on10descendants
- K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999 · 3 generations on9descendants
- K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001 · 4 generations on7descendants
- K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854791 | Bio-Fit Hip System | Richards Medical Co., Inc. | 1986 | — |
| +1 | K935921 | Zirconia Ceramic Femoral Head | Smith & Nephew Richards, Inc. | 1994 | — |
| +2 | K965002 | Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous… | Encore Orthopedics, Inc. | 1997 | — |
| +3 | K990261 | Plus Ceramic Head Prostheses (Alumina and Zirkonia) | Plus Orthopedics | 1999 | — |
| +4 | K012918 | Apex Modular Alumina Femoral Head | Apex Surgical, LLC | 2001 | — |
| +5 | K101451 | Apex Module Hip System Biolox Delta Femoral Head | Omni Life Science, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K935921 | Zirconia Ceramic Femoral Head | 1994 | 11 |
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, K935921 (Smith & Nephew Richards, Inc., 1994) has gone furthest, with 11 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 | — |
https://510kreport.com/device/K854791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K854791: Bio-Fit Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854791
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026