510(k) · Cleared
ClearedMets Modular Proximal Femur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stanmore Implants Worldwide, Ltd. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Sep 20, 2012 as substantially equivalent to K092138 (Stanmore Implants Worldwide, Ltd., 2011) and 3 other predicates after a 167-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Sep 20, 2012
- Review
- 167 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K021489 (2002). 5 ancestors in all, the oldest K963313 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021489 | Repiphysis Limb Salvage System | Wrightmedicaltechnologyinc | 2002 | — |
| −1 | K092138 | JTS Extendeable Implant | Stanmore Implants Worldwide, Ltd. | 2011 | 1 |
| 0 (this device) | K121056 | Mets Modular Proximal Femur | Stanmore Implants Worldwide, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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? (4)
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 |
|---|---|---|---|
| * | K092138 | JTS Extendeable ImplantSummary page 1…ssociates.com Tel: (781) 329-2993 Fax: (781) 329-2958 Equivalent to: ETS Extendible Implant, Stanmore Implants (K092 138) Orthopaedic Salvage System (OSS) Biomet (K002757) Global Modular Replacement Sys… | 2011 |
| * | K002757 | Oncology Salvage SystemSummary page 1…Fax: (781) 329-2958 Equivalent to: ETS Extendible Implant, Stanmore Implants (K092 138) Orthopaedic Salvage System (OSS) Biomet (K002757) Global Modular Replacement System (GMRS) Howmedica (Stryker) (K023087), Exactec… | 2000 |
| * | K023087 | Global Modular Replacement System (GMRS)Summary page 1…Orthopaedic Salvage System (OSS) Biomet (K002757) Global Modular Replacement System (GMRS) Howmedica (Stryker) (K023087), Exactec Inc All Poly Acetabular Cup (K9633 13) The single use METS® Modular Proximal Femur is a stand… | 2002 |
| * | K963313 | Exactech All Poly Acetabular CupSummary page 1…et (K002757) Global Modular Replacement System (GMRS) Howmedica (Stryker) (K023087), Exactec Inc All Poly Acetabular Cup (K9633 13) The single use METS® Modular Proximal Femur is a standard Device Description: modular system that… | 1996 |
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 10 years and passes through 2 companies; a new generation was cleared every 8.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- 6 other devices also cite its predicate K092138.
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. 2012, 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?
Intended for the replacement of diseased or deficient bone in the proximal femur. It is indicated for: Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint…
Read the full statement (120 words)
Intended for the replacement of diseased or deficient bone in the proximal femur. It is indicated for:
Limb salvage procedures where radical resection and replacement of the bone is required
Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies
Tumor resections
Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
Revision of previously failed total joint arthroplasty
Trauma
The METS® Modular Proximal Femur and its components are for single use Only
The METS® Modular Proximal Femur and its components are for cemented use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121056: Mets Modular Proximal Femur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121056
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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