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Escalade Acetabular System 170-0148

by Ortho Development Corp.

Escalade Acetabular System 170-0148 is a Class II device made by Ortho Development Corp., cleared under FDA 510(k) K103384 on 16 Mar 2011 and listed in FDA GUDID since 31 Aug 2015 (UDI-DI 00822409016822), active as of 23 Oct 2026. One FDA recall is linked to it.

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) K103384

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00822409016822 UDI-DI Date31 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103384 Date16 Mar 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103384 decided 16 Mar 2011 Active
  • FDA GUDID UDI-DI 00822409016822 listed 31 Aug 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-0740-2012 FDA Unclassified (pre-2012) initiated 19 Dec 2011

    Tip of hex-head screwdriver may break off during use in hip replacement procedure.

Timeline

3 dated events

  1. Cleared FDA 510(k) K103384
  2. Recall initiated FDA recalls Z-0740-2012
  3. Listed FDA GUDID 00822409016822

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Escalade Acetabular System
Generic name
Acetabular shell
Model / reference
170-0148
Primary DI / UDI-DI
00822409016822
510(k) Number
FDA product code
LPH, LZO
GMDN term
Acetabular shell
Device class
Class II
Regulation number
888.3358, 888.3353
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 48 Millimeter

Related devices

Category: Acetabular shell

Cleared under the same submission (K103384)

and 8 more cleared under K103384

Similar devices in this category

Other devices filed under Acetabular shell.

Other devices from Ortho Development Corp.

See all devices from Ortho Development Corp. →

Properties

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