510(k) · Cleared
Recalled · Class II · 2019Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, LLC · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jun 25, 2015 as substantially equivalent to K021260 (Biomet, Inc., 2002) and 7 other predicates after a 269-day review. Its family tree reaches back 11 generations to 1981. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Jun 25, 2015
- Review
- 269 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 6
- Predicates
- 8
Its longest line of descent runs back 11 generations to K810258 (1981). 128 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- 2 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- 1 generation backK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- This deviceK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015
- Descendant · cites it directly · 0 of its ownK253515 Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and…Biomet Orthopedics, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 4 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
- 3 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- 2 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- 1 generation backK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- This deviceK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015
Most influential descendants
Showing 1 of 1 · See all- K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −4 | K082996 | Biolox Delta Option Ceramic Heads | Biomet, Inc. | 2009 | 4 |
| −3 | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… | Biomet Manufacturing Corp | 2009 | — |
| −2 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| −1 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| 0 (this device) | K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | 2015 | — |
| +1 | K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 14 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 9 | 0 |
| 2000 | 9 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2005 | 8 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (8)
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 |
|---|---|---|---|
| * | K021260 | Reduced Size Oncology Salvage SystemSummary page 5…ted device(s) Biomet RS (Reduced Size) OSS Additional Components Primary to which equivalence is predicate for proximal tibia (K021260), claimed Biomet Vanguard Removable Molded Poly Tibia (K102580),… | 2002 |
| * | K102580 | Vanguard Removable Molded Poly TibiaSummary page 5…equivalence is predicate for proximal tibia (K021260), claimed Biomet Vanguard Removable Molded Poly Tibia (K102580), Stryker/Howmedica GMRS All Poly Tibia (K031480/K992346),… | 2011 |
| * | K031480 | Global Modular Replacement System Pediatric Tibial Bearing ComponentSummary page 5…Biomet Vanguard Removable Molded Poly Tibia (K102580), Stryker/Howmedica GMRS All Poly Tibia (K031480/K992346), Biomet Segmental Distal Femoral Component and Proximal… | 2003 |
| * | K992346 | Kinematic II Rotating Hinge KneeSummary page 5…Biomet Vanguard Removable Molded Poly Tibia (K102580), Stryker/Howmedica GMRS All Poly Tibia (K031480/K992346), Biomet Segmental Distal Femoral Component and Proximal… | 1999 |
| * | K080330 | Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…Summary page 5…mponent and Proximal Femoral Bodies – Primary predicate for proximal femur (K080330), Biomet G7 OsseoTi Acetabular Shell (K140669),… | 2008 |
| * | K140669 | G7 Osseoti Acetublar Shells Cleared while this submission was under review Summary page 5…predicate for proximal femur (K080330), Biomet G7 OsseoTi Acetabular Shell (K140669), Biomet OSS Les Proximal Component (K021380), and… | 2014 |
| * | K021380 | Oss Les Proximal Femoral ComponentSummary page 5…Biomet G7 OsseoTi Acetabular Shell (K140669), Biomet OSS Les Proximal Component (K021380), and Biomet Orthopaedic Salvage System-OSS (K141331)… | 2002 |
| * | K141331 | Biomet Orthopaedic Salvage System (Oss) Cleared while this submission was under review Summary page 5…Biomet OSS Les Proximal Component (K021380), and Biomet Orthopaedic Salvage System-OSS (K141331) Reference Items: Biomet Reconstructive Wedges (K122770),… | 2014 |
| † | K122770 | Biomet Reconstructive Wedges Model 110003660-99, 110003797-831 | 2013 |
| † | K072336 | Regenerex Porous Titanium Sleeve Augments | 2007 |
| † | K002757 | Oncology Salvage System | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2019 | Class II | Z-2234-2019 | Material/Component Contamination | Cleaning processes potentially being ineffective |
| Jul 2, 2019 | Class II | Z-2231-2019 | Material/Component Contamination | Cleaning processes potentially being ineffective |
| Jul 2, 2019 | Class II | Z-2236-2019 | Material/Component Contamination | Cleaning processes potentially being ineffective |
| Jul 2, 2019 | Class II | Z-2232-2019 | Material/Component Contamination | Cleaning processes potentially being ineffective |
| Jul 2, 2019 | Class II | Z-2235-2019 | Material/Component Contamination | Cleaning processes potentially being ineffective |
| Jul 2, 2019 | Class II | Z-2233-2019 | Material/Component Contamination | Cleaning processes potentially being ineffective |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 36 of the 128 ancestors have a recall of any class.
- Of its descendants, K253515 (Biomet Orthopedics, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K021260.
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. 2015, 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 (341 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.
EXPANDABLE INDICATIONS
The Biomet Side Access Distal Femoral Expandable offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement.
The devices are single use implants intended for implantation with bone cement or with Biomet Compress.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142814: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142814
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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