510(k) Report

510(k) · Cleared

Cleared

Metagen Activelock Cerclage System

K972327510(k) TraditionalCleared Aug 11, 199749-day reviewClass II21 CFR 888.3010

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

Pacific Materials and Interfaces · JDQ Cerclage, Fixation

Cleared on Aug 11, 1997 as substantially equivalent to K932024 (Encore Orthopedics, Inc., 1995) and 6 other predicates after a 49-day review. Its family tree reaches back 2 generations to 1988. 3 later devices descend from it.

Decided
Aug 11, 1997
Review
49 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K875156 (1988). 9 ancestors in all, the oldest K844068 (1985). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestors1990: 1 other ancestor1985: 1 other ancestor1998: 1 descendant cleared2006: 1 descendant cleared2009: 1 descendant clearedReference device: K892126 · Mitek Anchor · Mitek Surgical Products, Inc. · 1989Reference device: K894703 · Simon Nitinol Filter · Nitinol Medical Technologies, Inc. · 1990Reference device: K904785 · Cri Cynosar Catheter · Catheter Research C/O Burditt, Bowles & Radzius · 1991K875156 · Stainless Steel Orthopaedic Cable System · Richards Medical Co., Inc. · 1988K961283 · Dall-Miles Homogenous Vitallium Cable · Howmedica Corp. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K961283 · Dall-Miles Homogenous Vitallium Cable · Howmedica Corp. · 1996K875156 · Stainless Steel Orthopaedic Cable System · Richards Medical Co., Inc. · 19880
  1. Root · 2 generations backK875156 Stainless Steel Orthopaedic Cable SystemRichards Medical Co., Inc. · 1988
  2. 1 generation backK961283 Dall-Miles Homogenous Vitallium CableHowmedica Corp. · 1996
  3. This deviceK972327 Metagen Activelock Cerclage SystemPacific Materials and Interfaces · 1997
  4. Descendant · cites it directly · 2 of its ownK983976 Metagen Activelock Wire Cerclage SystemMetagen, LLC · 1998
  5. Descendant · 2 generations on · 1 of its ownK063009 Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None…Praesidia S.R.L. · 2006
  6. Descendant · 3 generations on · 0 of its ownK090686 Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009

Most influential descendants

Showing 3 of 3 · See all
  • K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC · 1998 · cites it directly2descendants
  • K063009Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)Praesidia S.R.L. · 2006 · 2 generations on1descendant
  • K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K875156Stainless Steel Orthopaedic Cable SystemRichards Medical Co., Inc.1988—
−1K961283Dall-Miles Homogenous Vitallium CableHowmedica Corp.1996—
0 (this device)K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces1997—
+1K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC1998—
+2K063009Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)Praesidia S.R.L.2006—
+3K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199010
199420
199520
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200610
200910
FIG. 1 — Lineage of K972327, 1988–2009Source: 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 JDQ? 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 JDQ device

  1. #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (8)

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
*K932024CCG Cerclage System
Summary page 5
…ic osteotomy. Design and Matenals The design and functional characteristics of the Metagen Activelock™ Cerclage System and the Encore Orthopedics (:C( {erclage System (K932024) arc fundamentally the suine. Eachiis a cerclage band system that inclndes a slide fastencr at one end that allows the band v enc…
Encore Orthopedics, Inc.1995—
*K934557Control Cable System
Summary page 6
…hreaded around the bone and fixing it in place while tension is maintained. Substantial equivalence to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569, K934058, K961283) is based on their use for fracture…
Depuy, Inc.1994—
*K844068Trochanter Cable Grip System
Summary page 6
…ion is maintained. Substantial equivalence to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569, K934058, K961283) is based on their use for fracture reduction and bony fragment consolidation by applying ten…
Howmedica Corp.1985—
*K900926Trochanter Cable Grip System (Add'l Indications)
Summary page 6
…intained. Substantial equivalence to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569, K934058, K961283) is based on their use for fracture reduction and bony fragment consolidation by applying tension to t…
Howmedica Corp.1990—
*K961569Dall-Miles Stainless Steel Beaded Cable
Summary page 6
…Substantial equivalence to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569, K934058, K961283) is based on their use for fracture reduction and bony fragment consolidation by applying tension to the device…
Howmedica Corp.1996—
*K934058Dall Miles System Minicleat
Summary page 6
…tial equivalence to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569, K934058, K961283) is based on their use for fracture reduction and bony fragment consolidation by applying tension to the device after it…
Howmedica Corp.1994—
*K961283Dall-Miles Homogenous Vitallium Cable
Summary page 6
…valence to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569, K934058, K961283) is based on their use for fracture reduction and bony fragment consolidation by applying tension to the device after it has been…
Howmedica Corp.1996—
*—Monofilament suture wire
Named without a submission number
—
†K892126Mitek AnchorMitek Surgical Products, Inc.1989—
†K894703Simon Nitinol FilterNitinol Medical Technologies, Inc.1990—
†K904785Cri Cynosar CatheterCatheter Research C/O Burditt, Bowles & Radzius1991—

Also cleared against K932024: 1 other device →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC19982

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 9 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K983976 (Metagen, LLC, 1998) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K932024.

How does its category compare?

All JDQ devices

JDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDQ

2in 2025

2007: 12008: 22009: 22011: 62012: 32013: 12014: 22015: 52016: 42017: 12018: 62020: 42022: 22023: 32024: 32025: 22026 (partial year): 1
2007high 6 (2011) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDQ

130in 2024

2011: 130 days median2012: 134 days median2015: 92 days median2016: 129 days median2018: 101 days median2020: 93 days median2023: 141 days median2024: 130 days median
2007high 141 (2023) · low 92 (2015)2026

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

Recalls per year · JDQ

5in 2019

2008: 22010: 22013: 12015: 12019: 5
2007high 5 (2019) · low 0 (2007)2026

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

Adverse event reports per year · JDQ

84in 2025

2007: 52008: 252009: 192010: 282011: 302012: 1302013: 3212014: 2232015: 2052016: 2242017: 1382018: 1822019: 1582020: 1252021: 1412022: 1342023: 982024: 1152025: 84
2007high 321 (2013) · low 5 (2007)2025

MAUDE reports naming product code JDQ, 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
20071—05
20082—225
20092—019
20100—228
20116130030
201231340130
20131—1321
20142—0223
20155921205
201641290224
20171—0138
201861010182
20190—5158
20204930125
20210—0141
20222—0134
20233141098
202431300115
20252—084
20261—0—

What is it indicated for?

Repair of long bone fractures due to trauma or reconstruction

Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy

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 K932024

1 other device cites the same predicate.

  • K973098Compression Cerclage Gundolf CCG-GFPlus Orthopedics · 1997

More from Pacific Materials and Interfaces

3 FDA decisions under this applicant name. See the company

  • K983360Macropore Protective SheetPacific Materials and Interfaces · 1999
  • K972913Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 1998

Recent decisions in JDQ

The JDQ category page

  • K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
  • K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025
  • K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc. · 2025
  • K232733Mbrace CableMedacta International S.A. · 2024
  • K233949ACCORD Cable SystemSmith & Nephew, Inc. · 2024

https://510kreport.com/device/K972327 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972327: Metagen Activelock Cerclage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972327

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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