510(k) · Cleared

Cleared

Reach Hip Component

K982367510(k) TraditionalCleared Aug 24, 199848-day reviewClass II21 CFR 888.3358

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

Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Aug 24, 1998 as substantially equivalent to K933942 (Depuy, Inc., 1994) and 4 other predicates after a 48-day review. Its family tree reaches back 1 generation to 1994. 209 later devices descend from it.

Decided: Aug 24, 1998
Review: 48 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K921225 (1994). 5 ancestors in all. 209 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK921225 Integral Total Hip SystemBiomet, Inc. · 1994
This deviceK982367 Reach Hip ComponentBiomet, Inc. · 1998
Descendant · cites it directly · 208 of its ownK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
Descendant · 2 generations on · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
Descendant · 2 generations on · 138 of its ownK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · Recalled
Descendant · 3 generations on · 137 of its ownK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · Recalled
Descendant · 4 generations on · 65 of its ownK093235 Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · Recalled

Showing 5 of 209 descendants. See all descendants

Descendants cleared per year

2003high 21 (2019) · low 0 (2004)2026

Most influential descendants

Showing 5 of 209 · See all

K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Biomet, Inc. · 2003 · cites it directly208descendants
K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · 2 generations on160descendants
K050124Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · 2 generations on138descendants
K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · 3 generations on137descendants
K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · 4 generations on65descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921225	Integral Total Hip System	Biomet, Inc.	1994	—
0 (this device)	K982367	Reach Hip Component	Biomet, Inc.	1998	—
+1	K030055	Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric…	Biomet, Inc.	2003	3
+2	K043537	Taperloc 12/14 Taper Femoral Components	Biomet, Inc.	2005	—
+2	K050124	Porous Coated Acetabular Components	Biomet, Inc.	2005	1
+3	K070369	Regenerx Ringloc + Modular Acetabular Shells	Biomet, Inc.	2007	19
+4	K093235	Ringloc + Hybrid Acetabular System	Biomet, Inc.	2010	30

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1996	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	5	0
2006	2	0
2007	3	0
2008	2	0
2009	1	0
2010	2	0
2011	4	0
2012	15	0
2013	10	0
2014	16	0
2015	11	0
2016	9	0
2017	12	0
2018	7	0
2019	21	0
2020	8	0
2021	8	0
2022	12	0
2023	14	0
2024	13	0
2025	16	0
2026	17	0

FIG. 1 — Lineage of K982367, 1994–2026Source: 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 LPH? 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 LPH device

#1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

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
*	K933942	Solution Bowed Femoral Hip Protsthesis Summary page 2 …ly equivalent to most femoral devices on the market in overall design and intended function. Predicate devices include: The Solution System® Depuy, Warsaw, IN 510(k) # K933942, K941942, K953703 Integral® Total Hip system, Biomet, Inc., Warsaw, IN 510(K) #K921255 Foundation® Porous Hip Stem, Encore Orthop…	Depuy, Inc.	1994	—
*	K941942	Solution Hip Summary page 2 …lent to most femoral devices on the market in overall design and intended function. Predicate devices include: The Solution System® Depuy, Warsaw, IN 510(k) # K933942, K941942, K953703 Integral® Total Hip system, Biomet, Inc., Warsaw, IN 510(K) #K921255 Foundation® Porous Hip Stem, Encore Orthopedics, Au…	Depuy, Inc.	1994	—
*	K953703	Depuy Vision Solution Hip Prosthesis Summary page 2 …ost femoral devices on the market in overall design and intended function. Predicate devices include: The Solution System® Depuy, Warsaw, IN 510(k) # K933942, K941942, K953703 Integral® Total Hip system, Biomet, Inc., Warsaw, IN 510(K) #K921255 Foundation® Porous Hip Stem, Encore Orthopedics, Austin TX 5…	Depuy, Inc.	1996	—
*	K921225	Integral Total Hip System Our OCR of the scanned summary read K921255, FDA’s number for Philips BV26 Mobile C-Arm Stand (Philips Medical Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Integral® Total Hip system”.	Biomet, Inc.	1994	—
*	K973302	Foundation Porous Hip Stem Summary page 2 …510(k) # K933942, K941942, K953703 Integral® Total Hip system, Biomet, Inc., Warsaw, IN 510(K) #K921255 Foundation® Porous Hip Stem, Encore Orthopedics, Austin TX 510(K) 973302 00061. C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corpora…	Encore Orthopedics, Inc.	1997	—

Also cleared against K933942: 1 other device →

What descends from it? (209)

See all 209

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030055	Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…	Biomet, Inc.	2003	208
K073637	Parallel-Sided Extensively Coated Femoral Stems	Biomet Manufacturing Corp	2008	0

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?

None of the 5 ancestors has a recall.
Of its descendants, K030055 (Biomet, Inc., 2003) has gone furthest, with 208 descendants of its own.
1 other device also cites its predicate K933942.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPH

12in 2025

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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	10	116	16	509
2008	10	86	1	706
2009	3	112	2	1,156
2010	15	100	22	2,007
2011	16	110	26	3,320
2012	25	76	30	3,785
2013	11	135	9	5,002
2014	20	129	3	5,163
2015	18	111	1	5,830
2016	10	150	8	4,900
2017	12	121	14	5,312
2018	9	145	2	5,954
2019	22	164	8	7,130
2020	7	164	6	5,429
2021	8	410	4	5,978
2022	14	247	2	5,223
2023	10	111	2	5,345
2024	6	92	1	5,626
2025	12	153	4	6,163
2026	8	256	2	—

What is it indicated for?

The indications for use of the Reach Femoral Component are:

a.) non-inflammatory degenerative disease

b.) osteoarthritis

c.) avascular necrosis

d.) rheumatoid arthritis

e.) revisions of hip replacement components

f.) treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement.

The Reach stem is intended for press-fit application and for single use implantation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982367 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982367: Reach Hip Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982367

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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