510(k) Report

510(k) · Cleared

Recalled · 2008

BMP Cable System

K982545510(k) TraditionalCleared Oct 19, 199890-day reviewClass II21 CFR 888.3010Recalls 1

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

Biomet, Inc. · JDQ Cerclage, Fixation

Cleared on Oct 19, 1998 as substantially equivalent to K971741 (Howmedica Corp., 1997) and 5 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1985. 17 later devices descend from it. It has been recalled once.

Decided
Oct 19, 1998
Review
90 days
Class
Class II
Product code
JDQ
Recalls
1
Predicates
6

Its longest line of descent runs back 3 generations to K844068 (1985). 14 ancestors in all. 17 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 2 other ancestors1994: 3 other ancestors1992: 1 other ancestor1995: 2 other ancestors1990: 1 other ancestor1988: 1 other ancestor2014: 1 descendant cleared2001: 1 descendant cleared2003: 3 descendants cleared2007: 1 descendant cleared2005: 1 descendant cleared2020: 1 descendant cleared2013: 1 descendant cleared2023: 2 descendants cleared2018: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant clearedK844068 · Trochanter Cable Grip System · Howmedica Corp. · 1985K961569 · Dall-Miles Stainless Steel Beaded Cable · Howmedica Corp. · 1996K971741 · Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable · Howmedica Corp. · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 4 other ancestors3 generations back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 7 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K971741 · Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable · Howmedica Corp. · 1997K961569 · Dall-Miles Stainless Steel Beaded Cable · Howmedica Corp. · 1996K844068 · Trochanter Cable Grip System · Howmedica Corp. · 19850
  1. Root · 3 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
  2. 2 generations backK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
  3. 1 generation backK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
  4. This deviceK982545 BMP Cable SystemBiomet, Inc. · 1998
  5. Descendant · cites it directly · 10 of its ownK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
  6. Descendant · 2 generations on · 3 of its ownK203405 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
  7. Descendant · 3 generations on · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
  8. Descendant · 2 generations on · 1 of its ownK223762 Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023
  9. Descendant · cites it directly · 1 of its ownK072250 Supercable Grip and Plate SystemKinamed, Inc. · 2007 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2001: 12003: 32005: 12007: 12013: 12014: 12018: 12020: 12021: 12022: 12023: 22024: 12025: 12026: 1
2001high 3 (2003) · low 0 (2002)2026

Most influential descendants

Showing 5 of 17 · See all
  • K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003 · cites it directly10descendants
  • K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021 · 2 generations on3descendants
  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · 3 generations on2descendants
  • K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023 · 2 generations on1descendant
  • K072250Supercable Grip and Plate SystemKinamed, Inc. · 2007 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K844068Trochanter Cable Grip SystemHowmedica Corp.1985—
−2K961569Dall-Miles Stainless Steel Beaded CableHowmedica Corp.1996—
−1K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp.1997—
0 (this device)K982545BMP Cable SystemBiomet, Inc.1998—
+1K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.2003—
+2K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.2021—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100…Smith & Nephew, Inc.20221
+2K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew2023—
+1K072250Supercable Grip and Plate SystemKinamed, Inc.20071

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199210
199430
199520
199720
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200330
200510
200710
201310
201410
201810
202010
202110
202210
202320
202410
202510
202610
FIG. 1 — Lineage of K982545, 1985–2026Source: 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 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
Get a 510(k) Report

What was it cleared against? (6)

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
*K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable
Summary page 2
…tially equivalent to most cable/Cerclage system on the market in overall design and intended function. Predicate devices include: Dall-Miles Cable System by Howmedica (K971741) Dall-Miles Trochanter Cable Grip System by Howmedica (K934058) Osteo-Clage Cable System by Acumed, Inc. (K921480) J-Fx Cerclag…
Howmedica Corp.1997—
*K934058Dall Miles System Minicleat
Summary page 2
…overall design and intended function. Predicate devices include: Dall-Miles Cable System by Howmedica (K971741) Dall-Miles Trochanter Cable Grip System by Howmedica (K934058) Osteo-Clage Cable System by Acumed, Inc. (K921480) J-Fx Cerclage System by Johnson and Johnson (K971682) Epi-Union Plating Syst…
Howmedica Corp.1994—
*K921480Osteo-Clage (TM) Cerciage Cable System
Summary page 2
…evices include: Dall-Miles Cable System by Howmedica (K971741) Dall-Miles Trochanter Cable Grip System by Howmedica (K934058) Osteo-Clage Cable System by Acumed, Inc. (K921480) J-Fx Cerclage System by Johnson and Johnson (K971682) Epi-Union Plating System by Howmedica (K974289) Osteo-Anatomical bone Pla…
Acu-Med, Inc.19921
*K971682J-FX Cerclage System
Summary page 2
…K971741) Dall-Miles Trochanter Cable Grip System by Howmedica (K934058) Osteo-Clage Cable System by Acumed, Inc. (K921480) J-Fx Cerclage System by Johnson and Johnson (K971682) Epi-Union Plating System by Howmedica (K974289) Osteo-Anatomical bone Plates by Oestonics Corp.(K972196) 0cos~…
Johnson & Johnson Professionals, Inc.1997—
*K974289Epi-Union Plating System
Summary page 2
…m by Howmedica (K934058) Osteo-Clage Cable System by Acumed, Inc. (K921480) J-Fx Cerclage System by Johnson and Johnson (K971682) Epi-Union Plating System by Howmedica (K974289) Osteo-Anatomical bone Plates by Oestonics Corp.(K972196) 0cos~ SERVICEg A [ ¥ S % C DEPARTMENT OF HEALTH & HUM…
Howmedica, Inc.1998—
*K972196Osteo Anatomical Bone Plates
Summary page 2
…ed, Inc. (K921480) J-Fx Cerclage System by Johnson and Johnson (K971682) Epi-Union Plating System by Howmedica (K974289) Osteo-Anatomical bone Plates by Oestonics Corp.(K972196) 0cos~ SERVICEg A [ ¥ S % C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service § REALTY <O 4y, u Foo…
Osteonics Corp.1997—

Also cleared against K971741: 4 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.200310
K072250Supercable Grip and Plate SystemKinamed, Inc.20071
K043252Cabling System Trochanter HookSmith & Nephew, Inc.20051
K133354Peri-Prosthetic Cable SystemBiomet, Inc.20140
K023564Osse-LignOsseus, LLC20030
K024022Osteo-Cable SleeveBiomet, Inc.20030
K013657Modification to: Biomet Humeral Cable PlatesBiomet Orthopedics, Inc.20010

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 24, 2008Not classifiedZ-0288-2009Labeling mix-upsThe outer package is properly labeled, but the inner package may be labeled as a femoral component.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 1 of the 14 ancestors has a recall of any class.
  • Of its descendants, K031162 (Smith & Nephew, Inc., 2003) has gone furthest, with 10 descendants of its own.
  • 4 other devices also cite its predicate K971741.

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?

Cable Implants: Femur and Tibial Fractures Prophylactic banding Trochanteric reattachment Olecranon fractures Patella fractures Ankle fractures Fixation of spiral fractures in conjunction with I/M nailing and screwing techniques. Sternum fixation after open chest surgery Stabilization of cortical onlay strut graft Trochanteric Grip: Reattachment of greater trochanter following osteomy for total hip or total hip Procedures or trochanteric advancement…

Read the full statement (104 words)

Cable Implants:

Femur and Tibial Fractures

Prophylactic banding

Trochanteric reattachment

Olecranon fractures

Patella fractures

Ankle fractures

Fixation of spiral fractures in conjunction with I/M nailing and screwing techniques.

Sternum fixation after open chest surgery

Stabilization of cortical onlay strut graft

Trochanteric Grip:

Reattachment of greater trochanter following osteomy for total hip or total hip Procedures or trochanteric advancement

Cable Plates

Fixation of femoral, tibial or humeral fractures near the site of an intramedullary implant

Fixation of fractures where a combination of screws and cerclage cables would improve stabilization

Supracondylar Cable Plate

Distal femoral fractures

Subtrochanteric fractures

Lateral Trochanteric Plate

Extended trochanteric osteomies

Trochanteric fractures

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K982545: BMP Cable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982545

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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