510(k) · Cleared
Recalled · Class II · 2014Sirius Femoral Stem
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 Aug 30, 2013 as substantially equivalent to K052639 (Biomet Manufacturing, Inc., 2006) and 1 other predicate after a 176-day review. Its family tree reaches back 3 generations to 2002. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 30, 2013
- Review
- 176 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K023085 (2002). 5 ancestors in all, the oldest K942028 (1994). 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK023085 RX 90 Femoral Stem and RX 90 Lateralized Femoral StemBiomet Orthopedics, Inc. · 2002
- 2 generations backK031734 Generation 4 Polished Femoral Hip ProsthesisBiomet, Inc. · 2003
- 1 generation backK052639 Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement…Biomet Manufacturing, Inc. · 2006
- This deviceK130610 Sirius Femoral StemBiomet, Inc. · 2013
- Descendant · cites it directly · 9 of its ownK142295 Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014
- Descendant · cites it directly · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
- Descendant · 2 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
- Descendant · 3 generations on · 5 of its ownK213701 Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
- Descendant · 2 generations on · 5 of its ownK191414 EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142295Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014 · cites it directly9descendants
- K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · cites it directly8descendants
- K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 2 generations on6descendants
- K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022 · 3 generations on5descendants
- K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K023085 | RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem | Biomet Orthopedics, Inc. | 2002 | — |
| −2 | K031734 | Generation 4 Polished Femoral Hip Prosthesis | Biomet, Inc. | 2003 | — |
| −1 | K052639 | Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer | Biomet Manufacturing, Inc. | 2006 | — |
| 0 (this device) | K130610 | Sirius Femoral Stem | Biomet, Inc. | 2013 | — |
| +1 | K142295 | Sirius Femoral Stem, Size 30A | Biomet, Inc. | 2014 | — |
| +1 | K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics | 2018 | 2 |
| +2 | K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020 | 1 |
| +3 | K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022 | — |
| +2 | K191414 | EXETER Centralizer, EXETER 2.5mm Plug | Stryker Orthopaedics | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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? (2)
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 |
|---|---|---|---|
| * | K052639 | Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement SpacerSummary page 2…ally Marketed Devices To Which Substantial Equivalence Is Claimed: Generation 4 (Gen 4) Polished Femoral Hip System with Proximal Cement Spacer - Biomet--(K052639) Collarless Polished Taper (CPT) Stem -Zimmer-(K960658) Device Description: The Sirius femoral stem is a highly polished… | 2006 |
| * | K960658 | Collarless Polished Taper Hip ProsthesisSummary page 2…med: Generation 4 (Gen 4) Polished Femoral Hip System with Proximal Cement Spacer - Biomet--(K052639) Collarless Polished Taper (CPT) Stem -Zimmer-(K960658) Device Description: The Sirius femoral stem is a highly polished, double-tapered, cemented stem designed to reduce hip pain fo… | 1996 |
What descends from it? (10)
2 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 |
|---|---|---|---|---|
| Dec 2, 2014 | Class II | Z-0822-2015 | Mixed-up of materials/components | After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 34B Catalog Number: 51-199333, Lot Number… |
| Dec 2, 2014 | Class II | Z-0823-2015 | Mixed-up of materials/components | After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 348 Catalog Number: 51-199333, Lot Number… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K142295 (Biomet, Inc., 2014) has gone furthest, with 9 descendants of its own.
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?
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed.
The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130610 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130610: Sirius Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130610
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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