PGR Hip Stem (Endoprosthesis) for Large Bone Resec

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K896851 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Moore Type Endo Prosthesis

  Class II

  FDA 510(k) K900051 Active Cleared 3 Oct 1990

• Sl-Self Locking Total Hip-Femoral Component

  Class II

  FDA 510(k) K902621 Active Cleared 11 Sep 1990

• Muller Type Acetabular Cup

  Class II

  FDA 510(k) K900257 Active Cleared 18 Apr 1990

• Lima Collared Cl Stem

  Class II

  FDA 510(k) K910836 Active Cleared 14 Jun 1991

• Cl Universal Hip Device

  Class II

  FDA 510(k) K885146 Active Cleared 24 Apr 1989

• Cl Hip Stem H/a Coated

  Class II

  FDA 510(k) K922613 Active Cleared 5 Apr 1994

See all devices from Lima Intl. Corp. →

• What is the PGR Hip Stem Endoprosthesis used for?

  The PGR Hip Stem is intended for use in hip arthroplasty procedures involving large bone resection, specifically in revision hip arthroplasty contexts where significant bone loss requires reconstruction with a cemented semi-constrained prosthesis.

• How is the PGR Hip Stem supplied and is it sterile or reusable?

  The device is a cemented hip prosthesis supplied as a sterile, single-use implant; it is not designed for reuse and must be implanted using standard surgical techniques for cemented components in revision surgery.

• What regulatory pathway was used for the PGR Hip Stem and what is its classification?

  The PGR Hip Stem received FDA 510(k) clearance under K896851 on January 1, 1991, and is classified as a Class II medical device under product code JDI, indicating it was found substantially equivalent to a predicate device.