FDA product code · Orthopedic
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
5 FDA decisions since 2012. 2 recalls name this code, 0 of them Class I. The most-cited predicate is K111481, named by 8 later devices.
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OQI 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 · OQI
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OQI
Too few OQI 510(k)s in any year since 2007 to give a median.
Recalls per year · OQI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQI
45in 2025
MAUDE reports naming product code OQI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 1 | 4 |
| 2023 | 0 | — | 1 | 23 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 1 | — | 0 | — |
Planning a device in OQI? 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) ReportRelated product codes
Other codes under 21 CFR 888.3353.