510(k) Report

510(k) · Cleared

Cleared

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System

K153242510(k) TraditionalCleared Jan 13, 201665-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

Frontier Medical Devices, Inc. · JDQ Cerclage, Fixation

Cleared on Jan 13, 2016 as substantially equivalent to K151888 (Frontier Medical Devices, Inc., 2015) and 3 other predicates after a 65-day review. Its family tree reaches back 3 generations to 1985.

Decided
Jan 13, 2016
Review
65 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K844068 (1985). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 3 other ancestors1990: 1 other ancestor1987: 1 other ancestorK844068 · Trochanter Cable Grip System · Howmedica Corp. · 1985K992616 · SDB Cerclage System · Pioneer Surgical Technology · 1999K151888 · Frontier Medical Devices In-line Orthopedic Cable Cerclage System · Frontier Medical Devices, Inc. · 20151985199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors3 generations back: 2 other ancestors K151888 · Frontier Medical Devices In-line Orthopedic Cable Cerclage System · Frontier Medical Devices, Inc. · 2015K992616 · SDB Cerclage System · Pioneer Surgical Technology · 1999K844068 · Trochanter Cable Grip System · Howmedica Corp. · 19850
  1. Root · 3 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
  2. 2 generations backK992616 SDB Cerclage SystemPioneer Surgical Technology · 1999
  3. 1 generation backK151888 Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2015
  4. This deviceK153242 Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K844068Trochanter Cable Grip SystemHowmedica Corp.1985—
−2K992616SDB Cerclage SystemPioneer Surgical Technology1999—
−1K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc.2015—
0 (this device)K153242Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199010
199430
FIG. 1 — Lineage of K153242, 1985–2016Source: 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? (5)

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
*K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage System
Summary page 4
…opaedic and Rehabilitation Devices Panel; Panel Code 87 Predicates: Frontier Medical Devices In-Line Orthopedic Cable Cerclage System (K151888) Zimmer Cable-Ready Cable Grip System (K935481 Pioneer Laboratories’ Songer Cable…
Frontier Medical Devices, Inc.2015—
*K935481Sponger Cable System, Modification
Summary page 4
…Frontier Medical Devices In-Line Orthopedic Cable Cerclage System (K151888) Zimmer Cable-Ready Cable Grip System (K935481 Pioneer Laboratories’ Songer Cable System, K940729 Pioneer Laboratories’ Bone Plate with…
Pioneer Surgical Technology1994—
*K940729Pioneer Laboratories Bone Plate with Cerclage Cables
Summary page 4
…(K151888) Zimmer Cable-Ready Cable Grip System (K935481 Pioneer Laboratories’ Songer Cable System, K940729 Pioneer Laboratories’ Bone Plate with Cerclage Cable, K941213 Pioneer Laboratories’ Songer Cable System)…
Pioneer Surgical Technology1994—
*K941213Songer Cable System
Summary page 4
…ystem (K935481 Pioneer Laboratories’ Songer Cable System, K940729 Pioneer Laboratories’ Bone Plate with Cerclage Cable, K941213 Pioneer Laboratories’ Songer Cable System) Description: The In-Line Orthopedic Cable Cerclage System consists of a cable…
Pioneer Surgical Technology1994—
*—Pioneer Laboratories’ Songer Cable System
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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 31 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
  • 1 of the 8 ancestors has a recall of any class.

How does its category compare?

All JDQ devices

JDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

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?

The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.

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

More from Frontier Medical Devices, Inc.

5 FDA decisions under this applicant name. See the company

  • K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2015
  • K151346Frontier Medical Devices Posterior Cable Screw SystemFrontier Medical Devices, Inc. · 2015
  • K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc. · 2015
  • K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc. · 2012

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/K153242 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153242: Frontier Medical Devices In-Line Orthopedic Cable 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/K153242

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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