Natural-Knee Congruent Tibial Insert With Screw

• • Terminated Z-1254-2014 FDA Class II ·initiated 25 Feb 2014

  A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

510(k) Number

K931651 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• Drg Cemeted Stem

  Class II

  FDA 510(k) K920003 Active Cleared 13 Mar 1992

• Intermedics Power Broach Impactor

  Class I

  FDA 510(k) K895121 Active Cleared 11 Sep 1989

• Intermedics High Tibial Osteotomy System

  Class II

  FDA 510(k) K892228 Active Cleared 6 Oct 1989

• Ioi Bipolar Prosthesis

  Class II

  FDA 510(k) K873815 Active Cleared 28 Oct 1987

• Select(R) Shoulder All Poly Glenoid

  Class II

  FDA 510(k) K935802 Active Cleared 22 May 1995

• Zweymueller Sl Femoral Hip Stem

  Class II

  FDA 510(k) K962101 Active Cleared 19 Aug 1996

See all devices from Intermedics Orthopedics →

• What types of knee surgeries is this tibial insert designed for, and how does it differ from other knee implants?

  This Natural-Knee Congruent Tibial Insert With Screw is specifically designed for use in total or partial knee arthroplasty, focusing on the patellofemoral compartment. It is a semi-constrained, cemented prosthesis made of a polymer/metal/polymer combination, which helps restore knee function and stability through congruent articulation. Unlike other knee implants, its semi-constrained design provides additional stability while maintaining natural knee movement, making it suitable for procedures where standard inserts may not offer enough support.

• Is this tibial insert intended for single-use or can it be reused after surgery?

  The Natural-Knee Congruent Tibial Insert With Screw is explicitly labeled as a single-use implant. It is intended for surgical use under sterile conditions, and reuse is not recommended or supported by the manufacturer. This aligns with standard orthopedic implant protocols to ensure patient safety and sterility.

• How should this device be stored to maintain its integrity before use?

  This device must be stored and handled according to standard orthopedic implant protocols to preserve sterility and structural integrity. Since it is a single-use, sterile implant, it should be kept in its original packaging until immediately before surgery, following manufacturer guidelines to prevent contamination or damage. Avoid exposure to moisture, extreme temperatures, or physical stress.

• What regulatory pathway did this device follow to gain market authorization, and what does that mean for its use?

  This device received FDA 510(k) clearance under the Traditional 510(k) Review pathway, with a decision code of SN (Substantially Equivalent) for some indications. This means the FDA determined it is substantially equivalent to a legally marketed predicate device in terms of technology and intended use. Clinically, this implies it has undergone review by the Orthopedic (OR) Advisory Committee and is approved for specific applications in knee arthroplasty, though the exact indications are tied to the predicate device’s claims.