510(k) · Cleared
ClearedRejuvenate Monolithic Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Dec 29, 2008 after a 90-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 29, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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 |
|---|---|---|---|
| * | — | Secur-Fit HA Stem Named without a submission number | |
| * | — | Accolade TMZF HA Stems Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The indications for use of the total hip replacement prostheses include:
1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2) Rheumatoid arthritis
3) Correction of functional deformity;
4) Revision procedures where other treatments or devices have failed; and,
5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
6) Stryker's Rejuvenate Hip System is intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082892: Rejuvenate Monolithic 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/K082892
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026