510(k) · Cleared

Cleared

Modular Reach Hip

K994038510(k) SpecialCleared Dec 22, 199923-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 22, 1999 as substantially equivalent to K921274 (Biomet, Inc., 1994) after a 23-day review. Its family tree reaches back 1 generation to 1994. 43 later devices descend from it.

Decided: Dec 22, 1999
Review: 23 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K921274 (1994). 43 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK921274 Metallic Toatal Hip SystemBiomet, Inc. · 1994
This deviceK994038 Modular Reach HipBiomet, Inc. · 1999
Descendant · cites it directly · 42 of its ownK022463 HA Modular Reach Proximal Porous and HA Modular Reach Collared…Biomet Orthopedics, Inc. · 2002
Descendant · 2 generations on · 39 of its ownK031693 Mallory/Head Modular Calcar with and Without HABiomet, Inc. · 2003 · Recalled
Descendant · 3 generations on · 38 of its ownK042774 Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc. · 2005
Descendant · cites it directly · 37 of its ownK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
Descendant · cites it directly · 27 of its ownK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2002high 6 (2025) · low 0 (2004)2026

Most influential descendants

Showing 5 of 43 · See all

K022463HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral…Biomet Orthopedics, Inc. · 2002 · cites it directly42descendants
K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc. · 2003 · 2 generations on39descendants
K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc. · 2005 · 3 generations on38descendants
K090757Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · cites it directly37descendants
K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 2010 · cites it directly27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921274	Metallic Toatal Hip System	Biomet, Inc.	1994	—
0 (this device)	K994038	Modular Reach Hip	Biomet, Inc.	1999	—
+1	K022463	HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous…	Biomet Orthopedics, Inc.	2002	—
+2	K031693	Mallory/Head Modular Calcar with and Without HA	Biomet, Inc.	2003	16
+3	K042774	Mallory-Head Modular Calcar Stems with Interlocking Slots	Biomet, Inc.	2005	—
+1	K090757	Biomet Modular Femoral Revision System	Biomet, Inc.	2009	18
+1	K092331	Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…	Encore Medical L.P.	2010	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2005	1	0
2006	1	0
2009	1	0
2010	2	0
2012	3	0
2013	1	0
2014	2	0
2015	5	0
2016	3	0
2017	4	0
2019	2	0
2020	2	0
2021	2	0
2022	2	0
2023	1	0
2024	1	0
2025	6	0
2026	2	0

FIG. 1 — Lineage of K994038, 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 24.2 · 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? (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
*	K921274	Metallic Toatal Hip System Summary page 1 …assification: Class 11 Device Product Code: 87LPH Device Description: The predicate to the Modular Reach Hip — the Mallory- Head Modular Hip - was previously cleared in K921274. The proximal portion of the predicate has been modified by removing A/P and lateral fins and adding an optional proximal collar.…	Biomet, Inc.	1994	—

Also cleared against K921274: 4 other devices →

What descends from it? (43)

See all 43

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

Number	Device	Applicant	Decided	Descendants
K022463	HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral…	Biomet Orthopedics, Inc.	2002	42
K090757	Biomet Modular Femoral Revision System	Biomet, Inc.	2009	37
K092331	Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;	Encore Medical L.P.	2010	27

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, K022463 (Biomet Orthopedics, Inc., 2002) has gone furthest, with 42 descendants of its own.
4 other devices also cite its predicate K921274.

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?

1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatment or devices have failed; 5) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

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/K994038 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994038: Modular Reach Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994038

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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