510(k) · Cleared
Recalled · 2009Modular Replacement System Cemented Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Jun 17, 2004 as substantially equivalent to K952970 (Howmedica Corp., 1996) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 17, 2004
- Review
- 86 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K952970 (1996). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK952970 Howmedica Femoral & Proximal Tibial Modular Replacement SytesmHowmedica Corp. · 1996 · Recalled
- This deviceK040749 Modular Replacement System Cemented StemsHowmedica Osteonics Corp. · 2004
- Descendant · cites it directly · 0 of its ownK241059 Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A · 2025
- Descendant · cites it directly · 0 of its ownK241716 Global Modular Replacement System, Modular Replacement System…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
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 |
|---|---|---|---|---|---|
| −1 | K952970 | Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm | Howmedica Corp. | 1996 | 13 |
| 0 (this device) | K040749 | Modular Replacement System Cemented Stems | Howmedica Osteonics Corp. | 2004 | — |
| +1 | K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | 2025 | — |
| +1 | K241716 | Global Modular Replacement System, Modular Replacement System, Modular… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 KRO? 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 KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952970 | Howmedica Femoral & Proximal Tibial Modular Replacement SytesmSummary page 1…Class II Device Product Code: OR(87) LPH and KRO Intended Use The Modular Replacement System (MRS - found substantially equivalent in K952970, K965164 and K972&1) has been successfully used in clinical situations where there is extensive bone loss due to tumor resectio… | 1996 |
| * | K965164 | Howmedica Modular Replacement System-Proximal FemurSummary page 1…Class II Device Product Code: OR(87) LPH and KRO Intended Use The Modular Replacement System (MRS - found substantially equivalent in K952970, K965164 and K972&1) has been successfully used in clinical situations where there is extensive bone loss due to tumor resection, and/or… | 1997 |
| Kept off the family tree | K972841 | Modular Replacement System (MRS) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2009 | Not classified | Z-1251-2009 | Labeling False and Misleading | Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, 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 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
Femoral and/or proximal tibial replacement due to
Trauma
Failed previous prosthesis
Tumor resection
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040749 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040749: Modular Replacement System Cemented Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040749
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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