510(k) · Cleared

Cleared

Reach Femoral Hip Component

K971824510(k) TraditionalCleared Dec 4, 1997202-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 Dec 4, 1997 as substantially equivalent to K933942 (Depuy, Inc., 1994) and 4 other predicates after a 202-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Dec 4, 1997
Review: 202 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. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK921225 Integral Total Hip SystemBiomet, Inc. · 1994
This deviceK971824 Reach Femoral Hip ComponentBiomet, Inc. · 1997
Descendant · cites it directly · 0 of its ownK984154 Apf Porous Coated Line ExtensionBiomet, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K984154Apf Porous Coated Line ExtensionBiomet, Inc. · 1999 · cites it directly0descendants

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)	K971824	Reach Femoral Hip Component	Biomet, Inc.	1997	—
+1	K984154	Apf Porous Coated Line Extension	Biomet, Inc.	1999	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K971824, 1994–1999Source: 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

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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
*	P820024	Prosthesis, Hip, Hemi-Femoral, Metal FDA lists this PMA only through its supplements; the earliest we hold is P820024/S001 (Mar 16, 1984). Summary page 2 …is substantially equivalent to almost all femoral devices on the market in overall design and intended function. Predicate devices include: AML® (Depuy, Warsaw, IN) PMA# P820024000 The Solution System® (Depuy, Warsaw, IN) -510(k)# K933942 -510(k)# K941942 -510(k)# K953703 integral® Total Hip System (Bio…	Depuy, Inc.		—
*	K933942	Solution Bowed Femoral Hip Protsthesis Summary page 2 …the market in overall design and intended function. Predicate devices include: AML® (Depuy, Warsaw, IN) PMA# P820024000 The Solution System® (Depuy, Warsaw, IN) -510(k)# K933942 -510(k)# K941942 -510(k)# K953703 integral® Total Hip System (Biomet, Inc., Warsaw, IN) -510(k) K921255 0C0o™1 4 === Page 3…	Depuy, Inc.	1994	—
*	K941942	Solution Hip Summary page 2 …all design and intended function. Predicate devices include: AML® (Depuy, Warsaw, IN) PMA# P820024000 The Solution System® (Depuy, Warsaw, IN) -510(k)# K933942 -510(k)# K941942 -510(k)# K953703 integral® Total Hip System (Biomet, Inc., Warsaw, IN) -510(k) K921255 0C0o™1 4 § REALTY o ¢ 4…	Depuy, Inc.	1994	—
*	K953703	Depuy Vision Solution Hip Prosthesis Summary page 2 …ended function. Predicate devices include: AML® (Depuy, Warsaw, IN) PMA# P820024000 The Solution System® (Depuy, Warsaw, IN) -510(k)# K933942 -510(k)# K941942 -510(k)# K953703 integral® Total Hip System (Biomet, Inc., Warsaw, IN) -510(k) K921255 0C0o™1 4 § REALTY o ¢ 4, C DEPARTMENT OF…	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	—

Also cleared against P820024: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K984154	Apf Porous Coated Line Extension	Biomet, Inc.	1999	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 4 ancestors has a recall.
Of its descendants, K984154 (Biomet, Inc., 1999) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate P820024.

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 Reach Femoral Component is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where previous hip replacement component failed. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnosis. The device is a single use implant. Use with a Biomet Ceramic Modular Head component or Hetal%ic Modular Head component with appropriate matching Type I Taper.

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/K971824 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971824: Reach Femoral 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/K971824

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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