510(k) Report

FDA product code · Orthopedic

Acid, Hyaluronic, Intraarticular

MOZClass IIIPMA required14 decisions since 19972 recalls

14 FDA decisions since 1997. 2 recalls name this code, 0 of them Class I.

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 MOZ 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 · MOZ

13in 2025

2007: 62008: 52009: 102010: 72011: 92012: 122013: 102014: 282015: 212016: 212017: 162018: 212019: 122020: 222021: 202022: 202023: 132024: 112025: 132026 (partial year): 8
2007high 28 (2014) · low 5 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOZ

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

Recalls per year · MOZ

1in 2017

2010: 12017: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · MOZ

176in 2025

2007: 1322008: 2222009: 3142010: 3232011: 3862012: 4622013: 6372014: 3402015: 2932016: 3132017: 5062018: 1,0992019: 5672020: 4412021: 3752022: 3052023: 4702024: 2922025: 176
2007high 1,099 (2018) · low 132 (2007)2025

MAUDE reports naming product code MOZ, 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
20076—0132
20085—0222
200910—0314
20107—1323
20119—0386
201212—0462
201310—0637
201428—0340
201521—0293
201621—0313
201716—1506
201821—01,099
201912—0567
202022—0441
202120—0375
202220—0305
202313—0470
202411—0292
202513—0176
20268—0—
FIG. 1 — MOZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MOZ? 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