510(k) Report

510(k) · Cleared

Cleared

HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral Stems

K022463510(k) SpecialCleared Aug 16, 200221-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 Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Aug 16, 2002 as substantially equivalent to K994038 (Biomet, Inc., 1999) after a 21-day review. Its family tree reaches back 2 generations to 1994. 42 later devices descend from it.

Decided
Aug 16, 2002
Review
21 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K921274 (1994). 42 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2003: 1 descendant cleared2009: 1 descendant cleared2005: 1 descendant cleared2012: 3 descendants cleared2015: 5 descendants cleared2010: 2 descendants cleared2025: 6 descendants cleared2013: 1 descendant cleared2016: 3 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2021: 2 descendants cleared2014: 2 descendants cleared2020: 2 descendants cleared2017: 4 descendants cleared2024: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants clearedK921274 · Metallic Toatal Hip System · Biomet, Inc. · 1994K994038 · Modular Reach Hip · Biomet, Inc. · 19991990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 7 descendants4 generations forward: 9 descendants5 generations forward: 12 descendants6 generations forward: 9 descendants K994038 · Modular Reach Hip · Biomet, Inc. · 1999K921274 · Metallic Toatal Hip System · Biomet, Inc. · 19940+5
  1. Root · 2 generations backK921274 Metallic Toatal Hip SystemBiomet, Inc. · 1994
  2. 1 generation backK994038 Modular Reach HipBiomet, Inc. · 1999
  3. This deviceK022463 HA Modular Reach Proximal Porous and HA Modular Reach Collared…Biomet Orthopedics, Inc. · 2002
  4. Descendant · cites it directly · 39 of its ownK031693 Mallory/Head Modular Calcar with and Without HABiomet, Inc. · 2003 · Recalled
  5. Descendant · 2 generations on · 38 of its ownK042774 Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc. · 2005
  6. Descendant · 2 generations on · 37 of its ownK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
  7. Descendant · 3 generations on · 27 of its ownK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
  8. Descendant · 4 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 12009: 12010: 22012: 32013: 12014: 22015: 52016: 32017: 42019: 22020: 22021: 22022: 22023: 12024: 12025: 62026: 2
2003high 6 (2025) · low 0 (2004)2026

Most influential descendants

Showing 5 of 42 · See all
  • K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc. · 2003 · cites it directly39descendants
  • K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc. · 2005 · 2 generations on38descendants
  • K090757Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · 2 generations on37descendants
  • K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 2010 · 3 generations on27descendants
  • K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K921274Metallic Toatal Hip SystemBiomet, Inc.1994—
−1K994038Modular Reach HipBiomet, Inc.1999—
0 (this device)K022463HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous…Biomet Orthopedics, Inc.2002—
+1K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.200316
+2K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc.2005—
+2K090757Biomet Modular Femoral Revision SystemBiomet, Inc.200918
+3K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P.20101
+4K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock…Lima Corporate S.P.A.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200610
200910
201020
201230
201310
201420
201550
201630
201740
201920
202020
202120
202220
202310
202410
202560
202620
FIG. 1 — Lineage of K022463, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K994038Modular Reach Hip
Summary page 1
…ned porous-coated uncemented prosthesis Device Classification: Class I1 Legally Marketed Device to which Substantial Equivalence is Claimed: Modular ReachTMHip- 510(k) K994038. Device Description: The HA Modular ReachTMProximal Porous and HA Modular ReachTMCollared Proximal Porous Femoral Stems are the…
Biomet, Inc.1999—

Also cleared against K994038: 2 other devices →

What descends from it? (42)

See all 42

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

NumberDeviceApplicantDecidedDescendants
K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.200339
K062383Unisyn HA Plasma Modular HipHayes Medical, Inc.20061

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 8 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K031693 (Biomet, Inc., 2003) has gone furthest, with 39 descendants of its own.
  • 2 other devices also cite its predicate K994038.

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

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
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

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

The indications for the HA Modular ReachTMProximal Porous and HA Modular ReachTM Collared Proximal Porous Femoral Stems are for ) 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; and 5 ) Revision procedures where other treatments or devices have failed.

Indications for use as stated in the FDA summary.

Also cleared against K994038

2 other devices cite the same predicate.

  • K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 20101 recall
  • K090757Biomet Modular Femoral Revision SystemBiomet, Inc. · 200918 recalls

More from Biomet Orthopedics, Inc.

35 FDA decisions under this applicant name. See the company

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  • K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 20082 recalls
  • K070955Acid Etched Lag ScrewsBiomet Orthopedics, Inc. · 2007
  • K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K022463 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022463: HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022463

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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