Medical Device Manufacturer · AU , Lane Cove

Signature Orthopaedics Pty, Ltd. - FDA 510(k) Cleared Devices

44 submissions · 44 cleared · Since 2012
44
Total
44
Cleared
0
Denied

Signature Orthopaedics Pty, Ltd. has 44 FDA 510(k) cleared orthopedic devices. Based in Lane Cove, AU.

Latest FDA clearance: Mar 2026. Active since 2012.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

44 devices
1–12 of 44
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
K252824 · Orthopedic
Mar 2026 188d
Active-V Total Knee System; World Total Knee System
K253239 · MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer · Orthopedic
Dec 2025 85d
Cambridge Partial Knee
K251771 · HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer · Orthopedic
Dec 2025 189d
Longboard Revision Hip Stem
K243021 · LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · Orthopedic
Aug 2025 314d
Freedom Posterior Cervical Screws
K242674 · NKG Posterior Cervical Screw System · Orthopedic
May 2025 249d
Shoulder Soft Tissue Anchors
K242477 · MBI Fastener, Fixation, Nondegradable, Soft Tissue · Orthopedic
May 2025 264d
Origin? Cemented Hip Stem
K243043 · LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · Orthopedic
May 2025 217d
Origin? TT Stem
K243029 · LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · Orthopedic
Mar 2025 165d
World Liner
K243162 · MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate · Orthopedic
Nov 2024 56d
Rx Knee System
K240683 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · Orthopedic
Sep 2024 183d
Logical Liner; World Liner; World Knee Patella
K241690 · MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate · Orthopedic
Aug 2024 50d
VerteLoc Spinal System
K231134 · MQP Spinal Vertebral Body Replacement Device · Orthopedic
Feb 2024 298d

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