510(k) · Cleared
Recalled · Class II · 2012Rejuvenate Modular Stem
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 Oct 20, 2009 as substantially equivalent to K071082 (Howmedica Osteonics Corp., 2007) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 2007. It has been recalled once.
- Decided
- Oct 20, 2009
- Review
- 60 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K071082 (2007). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK071082 Stryker Modular Hip SystemHowmedica Osteonics Corp. · 2007
- This deviceK092561 Rejuvenate Modular StemHowmedica Osteonics Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071082 | Stryker Modular Hip System | Howmedica Osteonics Corp. | 2007 | — |
| 0 (this device) | K092561 | Rejuvenate Modular Stem | Howmedica Osteonics Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 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 |
|---|---|---|---|
| * | K071082 | Stryker Modular Hip SystemSummary page 2…tantial Equivalence: With the addition of this line extension The Rejuvenate T M Modular Hip System is substantially equivalent to the Stryker Modular Hip cleared under K07 1082 and Rejuvenate TM Modular Hip System cleared under K08 1044 in regards to intended use, design, materials, and operational princi… | 2007 |
| * | K081044 | Rejuvenate Modular Hip SystemSummary page 2…on The Rejuvenate T M Modular Hip System is substantially equivalent to the Stryker Modular Hip cleared under K07 1082 and Rejuvenate TM Modular Hip System cleared under K08 1044 in regards to intended use, design, materials, and operational principles as a hip prosthesis. DEPARTMENT… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2012 | Class II | Z-2090-2012 | Device Design | Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K071082.
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. 2009, 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 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.
This hip is intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092561: Rejuvenate Modular Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092561
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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