ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR— 510(k) K121297

Clearance details

Applicant

Signature Orthopaedics Pty, Ltd.

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2012-04-30

Decision date

2012-12-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chatswood, AT

• 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

• K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head2026-03-12
• K253239 — Active-V Total Knee System; World Total Knee System2025-12-23
• K251771 — Cambridge Partial Knee2025-12-16
• K243021 — Longboard Revision Hip Stem2025-08-07
• K242674 — Freedom Posterior Cervical Screws2025-05-13

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 →

• Z-1694-2021 — Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.Class II·Terminated·Signature Orthopedics Pty Limited·20210420
• Z-0920-2018 — Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ¿ Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ¿ Inflammatory joint disease including rheumatoid arthritis ¿ Correction of functional deformity including congenital hip dysplasia ¿ Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ¿ Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacementClass II·Terminated·Signature Orthopedics Pty Limited·20180202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121297.