510(k) · Cleared
ClearedOss-Bodies Proximal Tibial Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Feb 15, 2006 as substantially equivalent to K052685 (Biomet, Inc., 2005) after a 28-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Feb 15, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002757 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (1)
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 |
|---|---|---|---|
| * | K052685 | Orthopedic Salvage System- OssSummary page 1…d, cemented, metal/polymer (888.3510, 87 KRO) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Orthopedic Salvage System- OSS (K052685) Device Description: The Orthopedic Salvage System- OSoffers a variety of component options for the treatment of patients that r… | 2005 |
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.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 4 other devices also cite its predicate K052685.
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?
1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved 2) Correction of varus, valgus, functional or post traumatic deformity 3) Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 4) Ligament deficiencies 5) Tumor resections 6) Treatment of non-unions, femoral neck fracture, and trochanteric fractures…
Read the full statement (110 words)
1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
2) Correction of varus, valgus, functional or post traumatic deformity
3) Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
4) Ligament deficiencies
5) Tumor resections
6) Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques*
7) Trauma
8) Revision of previously failed total joint arthroplasty
*Not applicable to Regenerex TM Ultra Porous Construct titanium knee augment usage, or any other knee component.
These devices are single use implants.
These devices are for cemented use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060131 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060131: Oss-Bodies Proximal Tibial Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060131
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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