510(k) · Cleared

Cleared

J-FX Cerclage System

K971682510(k) TraditionalCleared Jun 27, 199752-day reviewClass II21 CFR 888.3030

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

Johnson & Johnson Professionals, Inc. · LRN Wire, Surgical

Cleared on Jun 27, 1997 as substantially equivalent to K921480 (Acu-Med, Inc., 1992) and 2 other predicates after a 52-day review. Its family tree reaches back 1 generation to 1992. 24 later devices descend from it.

Decided: Jun 27, 1997
Review: 52 days
Class: Class II
Product code: LRN
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K921480 (1992). 3 ancestors in all. 24 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK921480 Osteo-Clage (TM) Cerciage Cable SystemAcu-Med, Inc. · 1992 · Recalled
This deviceK971682 J-FX Cerclage SystemJohnson & Johnson Professionals, Inc. · 1997
Descendant · cites it directly · 17 of its ownK982545 BMP Cable SystemBiomet, Inc. · 1998 · Recalled
Descendant · 2 generations on · 10 of its ownK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
Descendant · 3 generations on · 3 of its ownK203405 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
Descendant · 4 generations on · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

1998high 4 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 24 · See all

K982545BMP Cable SystemBiomet, Inc. · 1998 · cites it directly17descendants
K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003 · 2 generations on10descendants
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021 · 3 generations on3descendants
K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921480	Osteo-Clage (TM) Cerciage Cable System	Acu-Med, Inc.	1992	1
0 (this device)	K971682	J-FX Cerclage System	Johnson & Johnson Professionals, Inc.	1997	—
+1	K982545	BMP Cable System	Biomet, Inc.	1998	1
+2	K031162	Smith & Nephew Orthopaedic Cabling System	Smith & Nephew, Inc.	2003	—
+1	K231873	DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…	Depuy Ireland UC	2024	—
+3	K203405	EVOS Large Fragment Plating System	Smith & Nephew, Inc.	2021	—
+4	K213126	Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100…	Smith & Nephew, Inc.	2022	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	1	0
2003	3	0
2005	1	0
2007	1	0
2013	1	0
2014	1	0
2018	1	0
2020	1	0
2021	1	0
2022	1	0
2023	2	0
2024	3	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K971682, 1992–2026Source: 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 LRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (3)

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
*	K921480	Osteo-Clage (TM) Cerciage Cable System Summary page 1 …-Fx Cerclage System Performance Standards: No performance standards have been developed for this device. Predicate Device e OSTEO-CLAGE" Cable system by Acumed, Inc. (K921480) e DALL-MILES Trochanter Cable Grip System by Howmedica. (K934058) e FX-CABLELOK" System by Biodynamic Technologies, Inc. (K9356…	Acu-Med, Inc.	1992	1
*	K934058	Dall Miles System Minicleat Summary page 1 …have been developed for this device. Predicate Device e OSTEO-CLAGE" Cable system by Acumed, Inc. (K921480) e DALL-MILES Trochanter Cable Grip System by Howmedica. (K934058) e FX-CABLELOK" System by Biodynamic Technologies, Inc. (K935646) Description of Device The J-Fx Cerclage System consists of im…	Howmedica Corp.	1994	—
*	K935646	FX-Cablelok (TM) Stop (Trochanter Hook) System Summary page 1 …-CLAGE" Cable system by Acumed, Inc. (K921480) e DALL-MILES Trochanter Cable Grip System by Howmedica. (K934058) e FX-CABLELOK" System by Biodynamic Technologies, Inc. (K935646) Description of Device The J-Fx Cerclage System consists of implants and instruments. The implants are cables and sleeves in bo…	Biodynamic Technologies, Inc.	1994	—

Also cleared against K921480: 1 other device →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K982545	BMP Cable System	Biomet, Inc.	1998	17
K231873	DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…	Depuy Ireland UC	2024	5

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K982545 (Biomet, Inc., 1998) has gone furthest, with 17 descendants of its own.
1 other device also cites its predicate K921480.

How does its category compare?

All LRN devices

LRN Wire, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRN

FDA has decided no LRN device since 2007.

Median 510(k) review, days · LRN

Too few LRN 510(k)s in any year since 2007 to give a median.

Recalls per year · LRN

1in 2019

2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · LRN

81in 2025

2007high 140 (2023) · low 3 (2007)2025

MAUDE reports naming product code LRN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	3
2008	—	0	20
2009	—	0	31
2010	—	0	13
2011	—	0	6
2012	—	0	25
2013	—	0	108
2014	—	0	57
2015	—	0	24
2016	—	0	38
2017	—	0	33
2018	—	0	58
2019	—	1	84
2020	—	0	68
2021	—	0	118
2022	—	0	106
2023	—	0	140
2024	—	0	87
2025	—	0	81
2026	—	0	—

What is it indicated for?

The J-Fx Cerclage System is indicated for use in general orthopaedic repairs. This includes

such procedures as reinforcement of bone, reattachment of the greater trochanter, fixation of

long bone fracture with grafting, fixation of patellar fractures, and closure of sternum

following open heart surgery.

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/K971682 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971682: J-FX Cerclage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971682

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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