510(k) · Cleared
ClearedOss Modular Stems, Oss Diaphyseal Segments
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 Feb 27, 2013 as substantially equivalent to K002757 (Biomet, Inc., 2000) after a 106-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Feb 27, 2013
- Review
- 106 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002757 (2000). 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK002757 Oncology Salvage SystemBiomet, Inc. · 2000 · Recalled
- This deviceK123501 Oss Modular Stems, Oss Diaphyseal SegmentsBiomet, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK141331 Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK253515 Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and…Biomet Orthopedics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253434 OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK152621 OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014 · cites it directly3descendants
- K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC · 2015 · 2 generations on1descendant
- K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026 · 2 generations on0descendants
- K253434OSSTM Orthopedic Salvage SystemBiomet, 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 |
|---|---|---|---|---|---|
| −1 | K002757 | Oncology Salvage System | Biomet, Inc. | 2000 | 14 |
| 0 (this device) | K123501 | Oss Modular Stems, Oss Diaphyseal Segments | Biomet, Inc. | 2013 | — |
| +1 | K141331 | Biomet Orthopaedic Salvage System (Oss) | Biomet, Inc. | 2014 | — |
| +2 | K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | 2015 | 6 |
| +2 | K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | 2026 | — |
| +1 | K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | 2026 | — |
| +1 | K152621 | OSS/Arcos IM Total Femur Rod | Biomet, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2026 | 2 | 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? (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…int femorotibial metal/polymer constrained cemented prosthesis Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K002757 - Oncology Salvage System (Biomet) Device Description: The Orthopedic Salvage System is a system of modular and non-modular comp… | 2000 |
What descends from it? (6)
4 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?
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. 2013, 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?
Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures. Specific indications are: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. Correction of varus, valgus or post-traumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4.…
Read the full statement (182 words)
Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures. Specific indications are:
1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus or post-traumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.*
7. Revision of previously failed total joint arthroplasty.
8. Trauma.
These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).
*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123501: Oss Modular Stems, Oss Diaphyseal Segments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123501
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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