510(k) · Cleared

Recalled · Class II · 2018

Echo BI-Metric Press-Fit Stems

K070274510(k) SpecialCleared Apr 3, 200764-day reviewClass III21 CFR 888.3330Recalls 3

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

Biomet Manufacturing Corp · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Apr 3, 2007 as substantially equivalent to K063002 (Biomet Manufacturing Corp, 2006) after a 64-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it. It has been recalled 3 times.

Decided: Apr 3, 2007
Review: 64 days
Class: Class III
Product code: KWA
Recalls: 3
Predicates: 1

Its longest line of descent runs back 2 generations to K953925 (1996). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK953925 Fine Grain Cast Cobalt Chromium Hip StemsBiomet, Inc. · 1996
1 generation backK063002 Altra Press-Fit Hip SystemBiomet Manufacturing Corp · 2006
This deviceK070274 Echo BI-Metric Press-Fit StemsBiomet Manufacturing Corp · 2007
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
−2	K953925	Fine Grain Cast Cobalt Chromium Hip Stems	Biomet, Inc.	1996	—
−1	K063002	Altra Press-Fit Hip System	Biomet Manufacturing Corp	2006	—
0 (this device)	K070274	Echo BI-Metric Press-Fit Stems	Biomet Manufacturing Corp	2007	—
+1	K143009	Echo Bi-Metric Microplasty Hip System	Biomet, Inc.	2014	—
+2	K150503	Echo Bi-Metric Microplasty Line Extension	Biomet, Inc.	2015	—

Descendants by year cleared

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

FIG. 1 — Lineage of K070274, 1996–2015Source: 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? (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
*	K063002	Altra Press-Fit Hip System Summary page 1 …lymer cemented or uncemented prosthesis (21 CFR §888.3390) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Altra Press-Fit Hip Stem K063002 Biomet Manufacturing Corp. Device Description: The Echo Tm Bi-Metric® Press-Ft Stems are hip stems made from Ti-6AI-4V confor…	Biomet Manufacturing Corp	2006	—

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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 8, 2018	Class II	Z-2821-2018	Process control	Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
Jun 5, 2017	Class II	Z-0300-2018	Labeling False and Misleading	Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Nov 6, 2012	Class II	Z-0442-2013	Labeling Change Control	It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.7 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K143009 (Biomet, Inc., 2014) has gone furthest, with 1 descendant of its own.

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. 2007, this device’s year, is highlighted.

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. Noninflammatory 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.

The Echo TM Bi-Metric® Press-Fit Stems are intended for uncemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070274 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070274: Echo BI-Metric Press-Fit Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070274

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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