510(k) · Cleared

Cleared

Generation 4 Polished Femoral Hip Prosthesis

K031734510(k) SpecialCleared Jul 1, 200327-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 Jul 1, 2003 as substantially equivalent to K023085 (Biomet Orthopedics, Inc., 2002) after a 27-day review. Its family tree reaches back 1 generation to 2002. 12 later devices descend from it.

Decided: Jul 1, 2003
Review: 27 days
Class: Class II
Product code: JDI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K023085 (2002). 12 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK023085 RX 90 Femoral Stem and RX 90 Lateralized Femoral StemBiomet Orthopedics, Inc. · 2002
This deviceK031734 Generation 4 Polished Femoral Hip ProsthesisBiomet, Inc. · 2003
Descendant · cites it directly · 11 of its ownK052639 Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement…Biomet Manufacturing, Inc. · 2006
Descendant · 2 generations on · 10 of its ownK130610 Sirius Femoral StemBiomet, Inc. · 2013 · Recalled
Descendant · 3 generations on · 9 of its ownK142295 Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014
Descendant · 3 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
Descendant · 4 generations on · 6 of its ownK193429 Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2006high 2 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all

K052639Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement SpacerBiomet Manufacturing, Inc. · 2006 · cites it directly11descendants
K130610Sirius Femoral StemBiomet, Inc. · 2013 · 2 generations on10descendants
K142295Sirius Femoral Stem, Size 30ABiomet, Inc. · 2014 · 3 generations on9descendants
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 3 generations on8descendants
K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp. · 2020 · 4 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023085	RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem	Biomet Orthopedics, Inc.	2002	—
0 (this device)	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	—
+2	K130610	Sirius Femoral Stem	Biomet, Inc.	2013	2
+3	K142295	Sirius Femoral Stem, Size 30A	Biomet, Inc.	2014	—
+3	K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads	Stryker Orthopaedics	2018	2
+4	K193429	Exeter V40 Femoral Stem, Exeter X3 RimFit Cup	Howmedica Osteonics Corp.	2020	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2013	1	0
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

FIG. 1 — Lineage of K031734, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K023085	RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem Summary page 1 …lymer (888.3350) Product Code(s): J D I Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Rx-90 Cemented Hip Prosthesis - Biomet hc.(K023085). Device Description: The Generation 4 Polished Femoral Hip Prosthesis is a series ofinipplants meant to replace the patie…	Biomet Orthopedics, Inc.	2002	—

Also cleared against K023085: 1 other device →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K052639	Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer	Biomet Manufacturing, Inc.	2006	11

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?

Its one ancestor has no recall.
Of its descendants, K052639 (Biomet Manufacturing, Inc., 2006) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K023085.

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.

FDA decisions per year · JDI

1in 2025

2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

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

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

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?

The indications for use of the “Generation 4” Polished Femoral Hip Prosthesis include:

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 treatments or devices have failed.

The “Generation 4” Polished Femoral Hip Prosthesis is intended for total hip arthroplasty, and is intended for cemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031734 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031734: Generation 4 Polished Femoral Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031734

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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