510(k) Report

510(k) · Cleared

Cleared

Sirius Femoral Stem, Size 30A

K142295510(k) SpecialCleared Sep 15, 201428-day reviewClass II21 CFR 888.3350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Sep 15, 2014 as substantially equivalent to K130610 (Biomet, Inc., 2013) after a 28-day review. Its family tree reaches back 4 generations to 2002. 9 later devices descend from it.

Decided
Sep 15, 2014
Review
28 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K023085 (2002). 6 ancestors in all, the oldest K942028 (1994). 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1994: 1 other ancestor2018: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant cleared2025: 2 descendants clearedK023085 · RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem · Biomet Orthopedics, Inc. · 2002K031734 · Generation 4 Polished Femoral Hip Prosthesis · Biomet, Inc. · 2003K052639 · Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer · Biomet Manufacturing, Inc. · 2006K130610 · Sirius Femoral Stem · Biomet, Inc. · 2013 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 4 descendants K130610 · Sirius Femoral Stem · Biomet, Inc. · 2013 · recalledK052639 · Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer · Biomet Manufacturing, Inc. · 2006K031734 · Generation 4 Polished Femoral Hip Prosthesis · Biomet, Inc. · 2003K023085 · RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem · Biomet Orthopedics, Inc. · 20020
  1. Root · 4 generations backK023085 RX 90 Femoral Stem and RX 90 Lateralized Femoral StemBiomet Orthopedics, Inc. · 2002
  2. 3 generations backK031734 Generation 4 Polished Femoral Hip ProsthesisBiomet, Inc. · 2003
  3. 2 generations backK052639 Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement…Biomet Manufacturing, Inc. · 2006
  4. 1 generation backK130610 Sirius Femoral StemBiomet, Inc. · 2013 · Recalled
  5. This deviceK142295 Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014
  6. Descendant · cites it directly · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
  7. Descendant · 2 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled
  8. Descendant · 3 generations on · 5 of its ownK213701 Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2022
  9. Descendant · 2 generations on · 5 of its ownK191414 EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
  10. Descendant · 2 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2018: 12019: 12020: 12022: 12023: 12024: 12025: 22026: 1
2018high 2 (2025) · low 0 (2021)2026

Most influential descendants

Showing 5 of 9 · See all
  • 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
  • K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K023085RX 90 Femoral Stem and RX 90 Lateralized Femoral StemBiomet Orthopedics, Inc.2002—
−3K031734Generation 4 Polished Femoral Hip ProsthesisBiomet, Inc.2003—
−2K052639Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement SpacerBiomet Manufacturing, Inc.2006—
−1K130610Sirius Femoral StemBiomet, Inc.20132
0 (this device)K142295Sirius Femoral Stem, Size 30ABiomet, Inc.2014—
+1K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20182
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.20201
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics2022—
+2K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics2019—
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202010
202210
202310
202410
202520
202610
FIG. 1 — Lineage of K142295, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K130610Sirius Femoral Stem
Summary page 5
…ip) Metallic Cemented or Uncemented Prosthesis (21 CFR 888.3360) Legally marketed devices to which substantial equivalence is claimed: x K130610 – Sirius Femoral Stem – Biomet, Inc. Device Description The Sirius Femoral Stem is a highly polished, double-tapered, cemented s…
Biomet, Inc.20132

Also cleared against K130610: 1 other device →

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20188

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 12 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K173499 (Stryker Orthopaedics, 2018) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K130610.

How does its category compare?

All JDI devices

JDI 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

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—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 using 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.

Also cleared against K130610

1 other device cites the same predicate.

  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K142295 · printed Nov 5, 2026

Cite this page

510(k) Report. “K142295: Sirius Femoral Stem, Size 30A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142295

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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