510(k) · Cleared
ClearedMetagen Activelock Wire Cerclage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metagen, LLC · JDQ Cerclage, Fixation
Cleared on Dec 30, 1998 as substantially equivalent to K972327 (Pacific Materials and Interfaces, 1997) and 4 other predicates after a 51-day review. Its family tree reaches back 3 generations to 1988. 2 later devices descend from it.
- Decided
- Dec 30, 1998
- Review
- 51 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K875156 (1988). 10 ancestors in all, the oldest K844068 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK875156 Stainless Steel Orthopaedic Cable SystemRichards Medical Co., Inc. · 1988
- 2 generations backK961283 Dall-Miles Homogenous Vitallium CableHowmedica Corp. · 1996
- 1 generation backK972327 Metagen Activelock Cerclage SystemPacific Materials and Interfaces · 1997
- This deviceK983976 Metagen Activelock Wire Cerclage SystemMetagen, LLC · 1998
- Descendant · cites it directly · 1 of its ownK063009 Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None…Praesidia S.R.L. · 2006
- Descendant · 2 generations on · 0 of its ownK090686 Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875156 | Stainless Steel Orthopaedic Cable System | Richards Medical Co., Inc. | 1988 | — |
| −2 | K961283 | Dall-Miles Homogenous Vitallium Cable | Howmedica Corp. | 1996 | — |
| −1 | K972327 | Metagen Activelock Cerclage System | Pacific Materials and Interfaces | 1997 | — |
| 0 (this device) | K983976 | Metagen Activelock Wire Cerclage System | Metagen, LLC | 1998 | — |
| +1 | K063009 | Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes) | Praesidia S.R.L. | 2006 | — |
| +2 | K090686 | Sic Brevetti S.R.L. Device for Sternal Synthesis | Sic Brevetti S.R.L. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
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 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972327 | Metagen Activelock Cerclage SystemSummary page 4…lage System is substantially equivalent in indications and design principles to the following predicate or pre-amendment devices: * Metagen ActiveLock™ Cerclage System (K972327) featuring a bone Band device ¢ Monofilament wire from manufacturers such as Ethicon and Zimmer e DePuy Control Cable System e… | 1997 |
| * | K934557 | Control Cable SystemSummary page 5…eas the subject device is secured by a novel Clamping method. The subject device is also equivalent to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569). Clamping methods for the predicate and subject devic… | 1994 |
| * | K844068 | Trochanter Cable Grip SystemSummary page 5…hod. The subject device is also equivalent to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569). Clamping methods for the predicate and subject devices are similar. The predicate devices use a crimp, swage… | 1985 |
| * | K900926 | Trochanter Cable Grip System (Add'l Indications)Summary page 5…subject device is also equivalent to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569). Clamping methods for the predicate and subject devices are similar. The predicate devices use a crimp, swage or sleeve… | 1990 |
| * | K961569 | Dall-Miles Stainless Steel Beaded CableSummary page 5…device is also equivalent to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569). Clamping methods for the predicate and subject devices are similar. The predicate devices use a crimp, swage or sleeve in order… | 1996 |
| * | — | Monofilament wire from manufacturers such as Ethicon and Zimmer Named without a submission number | |
| * | — | Encore Orthopedics CCG Wire Cerclage System Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063009 | Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes) | 2006 | 1 |
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 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K063009 (Praesidia S.R.L., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, 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 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 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
Sternotomy closure
Sublaminar and intrafacet wiring of the spinal column
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/K983976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983976: Metagen Activelock Wire 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/K983976
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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