510(k) · Cleared
Recalled · 2007Orthopedic Salvage System- Oss
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Oct 27, 2005 as substantially equivalent to K002757 (Biomet, Inc., 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 27, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002757 (2000). 11 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK002757 Oncology Salvage SystemBiomet, Inc. · 2000 · Recalled
- This deviceK052685 Orthopedic Salvage System- OssBiomet, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK141331 Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK190100 USTAR II SystemUnited Orthopedic Corporation · 2019 · Recalled
- Descendant · cites it directly · 2 of its ownK080330 Segmental Distal Femoral Components and Proximal Femoral Bodies with…Biomet, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK083779 Mak Oss Knee Femoral ComponentsBiomet Manufacturing Corp · 2009 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014 · cites it directly3descendants
- K190100USTAR II SystemUnited Orthopedic Corporation · 2019 · cites it directly2descendants
- K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…Biomet, Inc. · 2008 · cites it directly2descendants
- K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC · 2015 · 2 generations on1descendant
- K083779Mak Oss Knee Femoral ComponentsBiomet Manufacturing Corp · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002757 | Oncology Salvage System | Biomet, Inc. | 2000 | 14 |
| 0 (this device) | K052685 | Orthopedic Salvage System- Oss | Biomet, Inc. | 2005 | — |
| +1 | K141331 | Biomet Orthopaedic Salvage System (Oss) | Biomet, Inc. | 2014 | — |
| +1 | K190100 | USTAR II System | United Orthopedic Corporation | 2019 | 5 |
| +1 | K080330 | Segmental Distal Femoral Components and Proximal Femoral Bodies with a… | Biomet, Inc. | 2008 | — |
| +2 | K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | 2015 | 6 |
| +1 | K083779 | Mak Oss Knee Femoral Components | Biomet Manufacturing Corp | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K002757 | Oncology Salvage SystemSummary page 1…ted, metal/polymer (888.3510, 87 KRO) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Orthopedic Salvage System- 055 (K002757) Device Description: The Orthopedic Salvage System- OSSoffers a variety of component options for the treatment of patients that… | 2000 |
What descends from it? (11)
See all 115 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 |
|---|---|---|---|---|
| Nov 7, 2007 | Not classified | Z-2214-2008 | Labeling mix-ups | Mislabeled as to size: Product is labeled as reduced size, but is actually standard size. |
| Nov 7, 2007 | Not classified | Z-2213-2008 | Labeling mix-ups | Mislabeled as to size: Product is labeled as reduced size, but is actually standard size. |
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?
The OSS bodies are indicated for cemented use only in cases of:
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052685: Orthopedic Salvage System- Oss.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052685
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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