510(k) Report

FDA product code · Orthopedic

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

PBIClass II21 CFR 888.3310510(k) required2 decisions since 20120 recalls

2 FDA decisions since 2012. 510(k) reviews decided 2021–2025 took a median of 261 days (half between 261 and 261). No recall names this code. The most-cited predicate is K121874, named by 11 later devices.

For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

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 PBI 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 · PBI

1in 2022

2012: 12022: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PBI

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

Recalls per year · PBI

No recall names PBI since 2007.

Adverse event reports per year · PBI

234in 2025

2015: 262016: 1992017: 2312018: 2782019: 2452020: 1852021: 1332022: 1282023: 2552024: 2552025: 234
2007high 278 (2018) · low 0 (2007)2025

MAUDE reports naming product code PBI, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20121—00
20130—00
20140—00
20150—026
20160—0199
20170—0231
20180—0278
20190—0245
20200—0185
20210—0133
20221—0128
20230—0255
20240—0255
20250—0234
20260—0—
FIG. 1 — PBI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PBI? 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

Which predicates do PBI devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K121874G7 Acetabular SystemBiomet Manufacturing Corp · 201211cite it

Which PBI devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc. · 202211generations
  • K121874G7 Acetabular SystemBiomet Manufacturing Corp · 20129generations

What has FDA decided in PBI lately?

  • K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc. · 2022
  • K121874G7 Acetabular SystemBiomet Manufacturing Corp · 20123 recalls

All 2 PBI decisions →

Related product codes

Other codes under 21 CFR 888.3310.

KWZ Prosthesis, Hip, Constrained, Cemented Or…