510(k) Report

FDA product code · Orthopedic

Cerclage, Fixation

JDQClass II21 CFR 888.3010510(k) required130 decisions since 198411 recalls

130 FDA decisions since 1984. 510(k) reviews decided 2021–2025 took a median of 136 days (half between 119 and 238). 11 recalls name this code, 0 of them Class I. The most-cited predicate is K935481, named by 9 later devices.

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

FIG. A — Illustration, orthopedic panel

Twenty years of JDQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — JDQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JDQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 888.3010.