510(k) · Cleared
ClearedOmnifit Constrained Acetabular Bearing Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Apr 7, 1989 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Apr 7, 1989
- Review
- 80 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK890197 Omnifit Constrained Acetabular Bearing InsertOsteonics Corp. · 1989
- Descendant · cites it directly · 0 of its ownK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890197 | Omnifit Constrained Acetabular Bearing Insert | Osteonics Corp. | 1989 | — |
| +1 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KWZ? 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 KWZ device
- #1 K241461 Mpact Constrained Linerscore 15.5 · 10 generations · no Class I recall
- #2 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained… | 2026 | 0 |
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, K261624 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KWZ devicesKWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWZ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWZ
193in 2025
MAUDE reports naming product code KWZ, 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 | 7 | 104 | 0 | 41 |
| 2008 | 1 | — | 0 | 44 |
| 2009 | 1 | — | 0 | 81 |
| 2010 | 1 | — | 8 | 98 |
| 2011 | 1 | — | 0 | 127 |
| 2012 | 1 | — | 1 | 168 |
| 2013 | 0 | — | 0 | 274 |
| 2014 | 0 | — | 0 | 278 |
| 2015 | 0 | — | 0 | 636 |
| 2016 | 1 | — | 0 | 1,180 |
| 2017 | 2 | — | 0 | 477 |
| 2018 | 0 | — | 0 | 283 |
| 2019 | 0 | — | 0 | 532 |
| 2020 | 0 | — | 0 | 288 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 1 | 164 |
| 2024 | 1 | — | 0 | 145 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K890197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K890197: Omnifit Constrained Acetabular Bearing Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K890197
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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