FDA product code · Orthopedic
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
1 FDA decision since 2020. No recall names this code. The most-cited predicate is K201315, named by 6 later devices.
Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PAO 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 · PAO
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PAO
Too few PAO 510(k)s in any year since 2007 to give a median.
Recalls per year · PAO
No recall names PAO since 2007.
Adverse event reports per year · PAO
88in 2025
MAUDE reports naming product code PAO, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 0 | — | 0 | 55 |
| 2016 | 0 | — | 0 | 63 |
| 2017 | 0 | — | 0 | 176 |
| 2018 | 0 | — | 0 | 96 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 64 |
| 2024 | 0 | — | 0 | 85 |
| 2025 | 0 | — | 0 | 88 |
| 2026 | 0 | — | 0 | — |
Planning a device in PAO? 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 888.3660.