The Progressive Orthopaedic Total Hip System— 510(k) K151424

Clearance details

Applicant

The Progressive Orthopaedic Company, LLC

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2015-05-28

Decision date

2016-07-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

North Palm Beach, FL, US

• K253630 — Mpact 3D Metal Foam2026-08-28
• K254043 — TRIVANCE Hip Stem2026-08-04
• K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
• K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05
• K251270 — Taperloc® Complete Hip Stem2026-05-19

• K183344 — The Progressive Orthopaedic Company Total Knee System II2019-03-18
• K150783 — Progressive Orthopaedic Total Knee System2015-06-23
• K142649 — Progressive Orthopedic Total Knee System2015-03-24
• K143314 — Progressive Orthopaedic Total Hip System2015-02-27

Death

73

Injury

31,640

Malfunction

3,358

Other

2

Total

35,073

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →