510(k) · Cleared
ClearedBiomet Orthopaedic Salvage System (Oss)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Oct 27, 2014 as substantially equivalent to K002757 (Biomet, Inc., 2000) and 5 other predicates after a 159-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.
- Decided
- Oct 27, 2014
- Review
- 159 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K945028 (1996). 12 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 3 generations backK013385 Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 2002 · Recalled
- 2 generations backK070978 Zimmer Segmental SystemZimmer, Inc. · 2007 · Recalled
- 1 generation backK110940 Zimmer Segment System Trabecular Metal Proximal Tibial Component…Zimmer, Inc. · 2011
- This deviceK141331 Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK253515 Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and…Biomet Orthopedics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK152621 OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC · 2015 · cites it directly1descendant
- K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026 · cites it directly0descendants
- K152621OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −3 | K013385 | Nexgen Complete Knee Solution Rotatng Hinge Knee | Zimmer, Inc. | 2002 | 2 |
| −2 | K070978 | Zimmer Segmental System | Zimmer, Inc. | 2007 | 6 |
| −1 | K110940 | Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular… | Zimmer, Inc. | 2011 | — |
| 0 (this device) | K141331 | Biomet Orthopaedic Salvage System (Oss) | Biomet, Inc. | 2014 | — |
| +1 | K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | 2015 | 6 |
| +1 | K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | 2026 | — |
| +1 | K152621 | OSS/Arcos IM Total Femur Rod | Biomet, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 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? (6)
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 5…Orthopedic Product Code(s) LPH; JDI; KRO Legally marketed device(s) Biomet Orthopaedic Salvage System (K002757, K052685, to which equivalence is K123501); claimed Biomet RS (Redu… | 2000 |
| * | K052685 | Orthopedic Salvage System- OssSummary page 5…Orthopedic Product Code(s) LPH; JDI; KRO Legally marketed device(s) Biomet Orthopaedic Salvage System (K002757, K052685, to which equivalence is K123501); claimed Biomet RS (Reduced Size)… | 2005 |
| * | K123501 | Oss Modular Stems, Oss Diaphyseal SegmentsSummary page 5…LPH; JDI; KRO Legally marketed device(s) Biomet Orthopaedic Salvage System (K002757, K052685, to which equivalence is K123501); claimed Biomet RS (Reduced Size) OSS Additional Components… | 2013 |
| * | K051479 | RS (Reduced Size) Oss (Orthopedic Salvage System) Additional ComponentsSummary page 5…K123501); claimed Biomet RS (Reduced Size) OSS Additional Components (K051479/K021260); Zimmer Segmental System Trabecular Metal Proximal Tibial… | 2005 |
| * | K021260 | Reduced Size Oncology Salvage SystemSummary page 5…K123501); claimed Biomet RS (Reduced Size) OSS Additional Components (K051479/K021260); Zimmer Segmental System Trabecular Metal Proximal Tibial… | 2002 |
| * | K110940 | Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…Summary page 5…emoral Component, and Additional Segment with Male/Female Taper Components (K110940) Reference Item: Biomet Reconstructive Wedges (K122770)… | 2011 |
| † | K122770 | Biomet Reconstructive Wedges Model 110003660-99, 110003797-831 | 2013 |
| † | K072336 | Regenerex Porous Titanium Sleeve Augments | 2007 |
What descends from it? (3)
3 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)
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 18 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 6 of the 12 ancestors have a recall of any class.
- Of its descendants, K142814 (Biomet Manufacturing, LLC, 2015) has gone furthest, with 1 descendant of its own.
- 20 other devices also cite its predicate K002757.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
OSS INDICATIONS 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or 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…
Read the full statement (251 words)
OSS INDICATIONS
1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or 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. Revision of previously failed total joint arthroplasty.
8. Trauma.
These devices are to be used with bone cement unless composed of OsseoTi (titanium alloy, not licensed in Canada) or a proximal femur is indicated for use (USA).
Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (USA).
* Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
COMPRESS INDICATIONS
The Compress Segmental Femoral Replacement System is indicated for:
1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
The Compress Segmental Femoral Replacement System components are intended for uncemented use.
When components of the Orthopaedic Salvage System are used with Biomet’s Compress Segmental Femoral Replacement System, the user should refer to the package insert contained with the Compress components for full prescription information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141331: Biomet Orthopaedic 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/K141331
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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