510(k) Report

510(k) · Cleared

Cleared

CCG Cerclage System

K932024510(k) TraditionalCleared Feb 14, 1995659-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

Encore Orthopedics, Inc. · JDQ Cerclage, Fixation

Cleared on Feb 14, 1995 after a 659-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 39 later devices descend from it.

Decided
Feb 14, 1995
Review
659 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
0

39 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1998: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2022: 4 descendants cleared2021: 2 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2024: 7 descendants cleared2025: 7 descendants cleared2018: 3 descendants cleared2017: 2 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK932024 CCG Cerclage SystemEncore Orthopedics, Inc. · 1995
  2. Descendant · cites it directly · 34 of its ownK973098 Compression Cerclage Gundolf CCG-GFPlus Orthopedics · 1997
  3. Descendant · 2 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  4. Descendant · 3 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  5. Descendant · 4 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  6. Descendant · 5 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

1997: 21998: 12006: 12009: 12013: 12014: 12017: 22018: 32020: 12021: 22022: 42023: 32024: 72025: 72026: 3
1997high 7 (2024) · low 0 (1999)2026

Most influential descendants

Showing 5 of 39 · See all
  • K973098Compression Cerclage Gundolf CCG-GFPlus Orthopedics · 1997 · cites it directly34descendants
  • K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on33descendants
  • K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 3 generations on32descendants
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 4 generations on14descendants
  • K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 5 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932024CCG Cerclage SystemEncore Orthopedics, Inc.1995—
+1K973098Compression Cerclage Gundolf CCG-GFPlus Orthopedics1997—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
200610
200910
201310
201410
201720
201830
202010
202120
202240
202330
202470
202570
202630
FIG. 1 — Lineage of K932024, 1995–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K973098Compression Cerclage Gundolf CCG-GFPlus Orthopedics199734
K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces19973

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?

  • Of its descendants, K973098 (Plus Orthopedics, 1997) has gone furthest, with 34 descendants of its own.

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—

More from Encore Orthopedics, Inc.

85 FDA decisions under this applicant name. See the company

  • K0329053DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc. · 2004
  • K0201143D KNEEEncore Orthopedics, Inc. · 20025 recalls
  • K020741Unicondylar KneeEncore Orthopedics, Inc. · 20022 recalls
  • K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  • K020170Keystone Hip System Calcar Replacement Body and Build UPEncore Orthopedics, Inc. · 2002

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/K932024 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932024: CCG 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/K932024

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026