510(k) · Cleared

Cleared

Balance Hip System

K050251510(k) TraditionalCleared May 27, 2005113-day reviewClass III21 CFR 888.3330

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

Biomet, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on May 27, 2005 as substantially equivalent to K921181 (Biomet, Inc., 1994) and 3 other predicates after a 113-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it.

Decided: May 27, 2005
Review: 113 days
Class: Class III
Product code: KWA
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K854046 (1985). 19 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
2 generations backK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
1 generation backK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
This deviceK050251 Balance Hip SystemBiomet, Inc. · 2005
Descendant · cites it directly · 1 of its ownK143009 Echo Bi-Metric Microplasty Hip SystemBiomet, Inc. · 2014
Descendant · 2 generations on · 0 of its ownK150503 Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc. · 2014 · cites it directly1descendant
K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K854046	Conical Collar Hip Prosthesis	Kirschner Medical Corp.	1985	—
−2	K960303	Fenning Femoral Component	Biomet, Inc.	1996	—
−1	K030055	Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric…	Biomet, Inc.	2003	3
0 (this device)	K050251	Balance Hip System	Biomet, Inc.	2005	—
+1	K143009	Echo Bi-Metric Microplasty Hip System	Biomet, Inc.	2014	—
+2	K150503	Echo Bi-Metric Microplasty Line Extension	Biomet, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1994	7	0
1995	1	0
1996	1	0
1997	2	0
1998	1	0
1999	2	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0

FIG. 1 — Lineage of K050251, 1985–2015Source: 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 KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K921181	Mallory-Head Total Hip System Summary page 2 …176 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Mallory - Head® Total Hip System - Biomet Inc. (K921181, K030055) Mayo® Conservative Hip Prosthesis - Zimmer Inc. (K943230) Bi-Metric® Total Hip Syst…	Biomet, Inc.	1994	—
*	K030055	Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral… Summary page 2 …176 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Mallory - Head® Total Hip System - Biomet Inc. (K921181, K030055) Mayo® Conservative Hip Prosthesis - Zimmer Inc. (K943230) Bi-Metric® Total Hip System - Biom…	Biomet, Inc.	2003	3
*	K943230	Mayo Hip Prosthesis Summary page 2 …lence Is Claimed: Mallory - Head® Total Hip System - Biomet Inc. (K921181, K030055) Mayo® Conservative Hip Prosthesis - Zimmer Inc. (K943230) Bi-Metric® Total Hip System - Biomet Inc. (K921224, K030055)…	Mayo Clinic	1997	—
*	K921224	Bimetric Total Hip System Summary page 2 …- Biomet Inc. (K921181, K030055) Mayo® Conservative Hip Prosthesis - Zimmer Inc. (K943230) Bi-Metric® Total Hip System - Biomet Inc. (K921224, K030055) stems available Device Descr…	Biomet, Inc.	1994	—

Also cleared against K921181: 5 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K143009	Echo Bi-Metric Microplasty Hip System	Biomet, Inc.	2014	1

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 20 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
2 of the 19 ancestors have a recall of any class.
Of its descendants, K143009 (Biomet, Inc., 2014) has gone furthest, with 1 descendant of its own.
5 other devices also cite its predicate K921181.

How does its category compare?

All KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWA

4in 2012

2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007high 167 (2010) · low 57 (2008)2026

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

Recalls per year · KWA

19in 2023

2007high 84 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWA

1,216in 2025

2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, 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	8	74	0	213
2008	9	57	13	762
2009	7	139	0	820
2010	6	167	84	3,348
2011	11	101	28	17,737
2012	4	76	21	24,601
2013	0	—	1	20,020
2014	0	—	0	16,494
2015	0	—	0	12,339
2016	0	—	1	7,872
2017	0	—	1	6,847
2018	0	—	1	6,388
2019	0	—	2	7,628
2020	0	—	1	4,538
2021	0	—	0	2,064
2022	0	—	0	1,617
2023	0	—	19	1,474
2024	0	—	0	1,168
2025	0	—	0	1,216
2026	0	—	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 of previously failed total hip arthroplasty. Balance® Hip System Femoral Stems are intended for uncemented use only. 1.…

Read the full statement (117 words)

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 of previously failed total hip arthroplasty.

Balance® Hip System Femoral Stems are intended for uncemented use only.

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 of previously failed femoral head resurfacing components.

Balance® Hip System Microplasty® Stems are intended for uncemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050251: Balance Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050251

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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