Natural-Knee(R) with CSTI(TM)

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

Natural-Knee(R) and Natural Knee(R)II W/Csti(Tm)

Generic Name

PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

PMA Number

P940002 ↗

FDA Product Code

MBD

Device Class

Class III

Advisory Committee

Orthopedic

FDA Decision

APRL

• Sulzer Vascutek ePTFE Vascular Prosthesis

  Class II

  FDA 510(k) K992832 Active Cleared 19 Nov 1999

• APR Metasul Acetabular Insert

  Class III

  FDA 510(k) K993569 Active Cleared 1 Dec 1999

• Sulzer Vascutek Gelsoft Vascular Prosthesis

  Class II

  FDA 510(k) K990503 Active Cleared 9 Dec 1999

• Modified to Modular FR Severe Bone Loss Trauma

  Class II

  FDA 510(k) K002324 Active Cleared 24 Aug 2000

• Sulzer Vascutek Sealptfe Vascular Prosthesis

  Class II

  FDA 510(k) K993667 Active Cleared 28 Jan 2000

• What is the Natural-Knee(R) with CSTI(TM) indicated for?

  The Natural-Knee(R) with CSTI(TM) is indicated for uncemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of noninflammatory degenerative joint disease (NIDJD) or inflammatory joint disease (IJD).

• Who manufactures the Natural-Knee(R) with CSTI(TM)?

  The Natural-Knee(R) with CSTI(TM) is manufactured by Sulzermedica, as stated in the manufacturer and applicant fields of the device data.

• What regulatory authorization does the Natural-Knee(R) with CSTI(TM) have?

  The Natural-Knee(R) with CSTI(TM) has FDA PMA authorization, as indicated by the AUTHORIZATIONS field showing FDA_PMA and the PMA number P940002.