510(k) Report

510(k) · Cleared

Cleared

Activelock Modular Femoral Hip System

K980020510(k) TraditionalCleared Apr 3, 199888-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

Metagen, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Apr 3, 1998 as substantially equivalent to K942027 (Biomet, Inc., 1994) and 6 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.

Decided
Apr 3, 1998
Review
88 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K851422 (1985). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 3 other ancestors1991: 3 other ancestors2000: 1 descendant cleared2004: 1 descendant clearedK851422 · S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip · Joint Medical Products Corp. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K851422 · S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip · Joint Medical Products Corp. · 19850
  1. Root · 1 generation backK851422 S-Rom 135 Femoral Stem & Collar (Part of S-Rom HipJoint Medical Products Corp. · 1985
  2. This deviceK980020 Activelock Modular Femoral Hip SystemMetagen, LLC · 1998
  3. Descendant · cites it directly · 1 of its ownK992815 The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2000 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK032641 Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2004 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K992815The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2000 · cites it directly1descendant
  • K032641Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K851422S-Rom 135 Femoral Stem & Collar (Part of S-Rom HipJoint Medical Products Corp.1985—
0 (this device)K980020Activelock Modular Femoral Hip SystemMetagen, LLC1998—
+1K992815The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd.200071
+2K032641Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd.200471

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199130
199430

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200410
FIG. 1 — Lineage of K980020, 1985–2004Source: 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 24.2 · 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? (7)

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
*K942027Impact CO-CR 1-Piece Femoral Component
Summary page 2
…to several pre-amendment and post-amendment 510(k) Summary Metagen Modular Hip System Page XI-2 devices, including implants marketed by Biomet (Impact, K942027; Mallory-Head Modular Porous Series, K921181), Joint Medical Products Corporation/Johnson & Johnson (S-ROM, K851422, K912713, K91…
Biomet, Inc.1994—
*K921181Mallory-Head Total Hip System
Summary page 2
…510(k) Summary Metagen Modular Hip System Page XI-2 devices, including implants marketed by Biomet (Impact, K942027; Mallory-Head Modular Porous Series, K921181), Joint Medical Products Corporation/Johnson & Johnson (S-ROM, K851422, K912713, K913231), Wright Medical Technology (Infinity, K…
Biomet, Inc.1994—
*K851422S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip
Summary page 2
…vices, including implants marketed by Biomet (Impact, K942027; Mallory-Head Modular Porous Series, K921181), Joint Medical Products Corporation/Johnson & Johnson (S-ROM, K851422, K912713, K913231), Wright Medical Technology (Infinity, K942115), and Smith & Nephew Richards (RMHS, K912593). DEVICE DESCRIPTI…
Joint Medical Products Corp.1985—
*K912713S-Rom ZT HA Proximal Femoral Sleeve
Summary page 2
…cluding implants marketed by Biomet (Impact, K942027; Mallory-Head Modular Porous Series, K921181), Joint Medical Products Corporation/Johnson & Johnson (S-ROM, K851422, K912713, K913231), Wright Medical Technology (Infinity, K942115), and Smith & Nephew Richards (RMHS, K912593). DEVICE DESCRIPTION Inten…
Joint Medical Products Corp.1991—
*K913231S-Rom (TM) Total Lhip System W/Ceramic Head
Summary page 2
…mplants marketed by Biomet (Impact, K942027; Mallory-Head Modular Porous Series, K921181), Joint Medical Products Corporation/Johnson & Johnson (S-ROM, K851422, K912713, K913231), Wright Medical Technology (Infinity, K942115), and Smith & Nephew Richards (RMHS, K912593). DEVICE DESCRIPTION Intended Use…
Joint Medical Products Corp.1991—
*K942115Infinity Revision Hip Stem
Summary page 2
…llory-Head Modular Porous Series, K921181), Joint Medical Products Corporation/Johnson & Johnson (S-ROM, K851422, K912713, K913231), Wright Medical Technology (Infinity, K942115), and Smith & Nephew Richards (RMHS, K912593). DEVICE DESCRIPTION Intended Use The ActiveLock™ Modular Femoral Hip System is i…
Wrightmedicaltechnologyinc1994—
*K912593Modular Hip System
Summary page 2
…oint Medical Products Corporation/Johnson & Johnson (S-ROM, K851422, K912713, K913231), Wright Medical Technology (Infinity, K942115), and Smith & Nephew Richards (RMHS, K912593). DEVICE DESCRIPTION Intended Use The ActiveLock™ Modular Femoral Hip System is intended for primary or revision reconstructio…
Smith & Nephew Richards, Inc.1991—

Also cleared against K942027: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K992815The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd.20001

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 7 ancestors has a recall.
  • Of its descendants, K992815 (Portland Orthopaedics Pty., Ltd., 2000) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K942027.

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 ActiveLock™ Modular Femoral Hip System is intended for primary or revision reconstruction, with or without bone cement, of the femoral portion of severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present.

Clinical Indications for Use are:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

2. rheumatoid arthritis;

3. correction of functional deformity;

4. revision procedures where other treatments or devices have failed; and,

5. treatment of nonunion, femoral neck 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.

Also cleared against K942027

1 other device cites the same predicate.

  • K992815The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 200071 recalls

More from Metagen, LLC

5 FDA decisions under this applicant name. See the company

  • K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC · 1998
  • K980609Segmental Defect Replacement SystemMetagen, LLC · 1998
  • K964003Metagen All Poly Acetabular Cup SystemMetagen, LLC · 1997
  • K963700Metagen High Tibial Osteotomy SystemMetagen, LLC · 1997

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/K980020 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980020: Activelock Modular Femoral Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980020

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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