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B-P Total Hip System 01-01-0052

by Endotec, Inc.

B-P Total Hip System 01-01-0052 is a Class II device made by Endotec, Inc., cleared under FDA 510(k) K963101 on 12 Feb 1997 and listed in FDA GUDID since 17 Sep 2015 (UDI-DI 00814193022479), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K963101

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814193022479 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK963101 Date12 Feb 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K963101 decided 12 Feb 1997 Active
  • FDA GUDID UDI-DI 00814193022479 listed 17 Sep 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1623-2010 FDA Unclassified (pre-2012) initiated 5 Jun 2009 on shared 510(k) K963101

    Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K963101
  2. Recall initiated FDA recalls Z-1623-2010
  3. Listed FDA GUDID 00814193022479

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
B-P Total Hip System
Generic name
Ceramic-on-polyethylene total hip prosthesis
Model / Ref / Catalog
01-01-0052
Primary DI / UDI-DI
00814193022479
510(k) Number
FDA product code
JDI, LPH
GMDN term
Ceramic-on-polyethylene total hip prosthesis
Device class
Class II
Regulation number
888.3350, 888.3358
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 52 Millimeter

Related devices

Category: Ceramic-on-polyethylene total hip prosthesis

Cleared under the same submission (K963101)

and 8 more cleared under K963101

Other devices from Endotec, Inc.

See all devices from Endotec, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)