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Conformity Stem, Cemented

by United Orthopedic Corporation

510(k) K191056

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK191056 Date3 Jan 2020ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JDI
Device class
Class II
Regulation
21 CFR Part 888.3350
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Conformity Stem, Cemented is a cemented femoral stem designed for hip arthroplasty, featuring a hydroxyapatite (HA) coating for enhanced osseointegration. It is classified under orthopedic implants and is intended for use in total hip replacement procedures to provide structural support within the femur.

This device is supplied as a cemented option, requiring fixation with bone cement during surgical implantation. It is regulated under FDA 510(k) clearance (K191056) and is intended for single-use in sterile conditions. The product is available in standard and high-offset configurations to accommodate varying biomechanical needs, ensuring optimal soft-tissue tension and joint stability.

From the manufacturer

The Conformity stem is a classic, fully Hydroxyapatite (HA) coated femoral stem with a unique profile for ideal biomechanical performance. Standard and high offset options enable the surgeon to finely adjust the tension for soft tissues around the hip joint to help achieve better joint stability.

Source: us.unitedorthopedic.com

Conformity Stem - The Conformity Stem platform provides a comprehensive stem solution to hip arthroplasty surgery.

Source: unitedorthopedic.com

Devices cleared under K191056

65 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K191056
UDI-DISize and differences
Conformity Stem 9110-5010
UNITED ORTHOPEDIC CORP.
9110-5010 / 9110-501004711605586573
Single use: no
On the market
Conformity Stem 9110-5020
UNITED ORTHOPEDIC CORP.
9110-5020 / 9110-502004711605586597
Single use: no
On the market
Conformity Stem 9110-6001
UNITED ORTHOPEDIC CORP.
9110-6001 / 9110-600104711605585354
Single use: no
On the market
Conformity Stem 9110-6001-RB
UNITED ORTHOPEDIC CORP.
9110-6001-RB / 9110-6001-RB04719886896077
Single use: no
On the market
Conformity Stem 9110-6003
UNITED ORTHOPEDIC CORP.
9110-6003 / 9110-600304711605585378
Single use: no
On the market
Conformity Stem 9110-6003-RB
UNITED ORTHOPEDIC CORP.
9110-6003-RB / 9110-6003-RB04719886896091
Single use: no
On the market
Conformity Stem 9110-6004-RB
UNITED ORTHOPEDIC CORP.
9110-6004-RB / 9110-6004-RB04719886896107
Single use: no
On the market
Conformity Stem 9110-6005
UNITED ORTHOPEDIC CORP.
9110-6005 / 9110-600504711605585392
Single use: no
On the market
Conformity Stem 9110-6006
UNITED ORTHOPEDIC CORP.
9110-6006 / 9110-600604711605585408
Single use: no
On the market
Conformity Stem 9110-6006-RB
UNITED ORTHOPEDIC CORP.
9110-6006-RB / 9110-6006-RB04719886896121
Single use: no
On the market
Conformity Stem 9110-6007
UNITED ORTHOPEDIC CORP.
9110-6007 / 9110-600704711605585415
Single use: no
On the market
Conformity Stem 9110-6007-RB
UNITED ORTHOPEDIC CORP.
9110-6007-RB / 9110-6007-RB04719886896138
Single use: no
On the market
Conformity Stem 9110-6008
UNITED ORTHOPEDIC CORP.
9110-6008 / 9110-600804711605585422
Single use: no
On the market
Conformity Stem 9110-6008-RB
UNITED ORTHOPEDIC CORP.
9110-6008-RB / 9110-6008-RB04719886896145
Single use: no
On the market
Conformity Stem 9110-6009
UNITED ORTHOPEDIC CORP.
9110-6009 / 9110-600904711605585439
Single use: no
On the market
Conformity Stem 9110-6009-RB
UNITED ORTHOPEDIC CORP.
9110-6009-RB / 9110-6009-RB04719886896152
Single use: no
On the market
Conformity Stem 9110-6011
UNITED ORTHOPEDIC CORP.
9110-6011 / 9110-601104711605585453
Single use: no
On the market
Conformity Stem 9110-6011-RB
UNITED ORTHOPEDIC CORP.
9110-6011-RB / 9110-6011-RB04719886896176
Single use: no
On the market
Conformity Stem 9110-8101
UNITED ORTHOPEDIC CORP.
9110-8101 / 9110-810104711605587075
Single use: no
On the market
Conformity Stem 9110-8102
UNITED ORTHOPEDIC CORP.
9110-8102 / 9110-810204711605587082
Single use: no
On the market
Conformity Stem 9110-8103
UNITED ORTHOPEDIC CORP.
9110-8103 / 9110-810304711605587099
Single use: no
On the market
Conformity Stem 9110-8104
UNITED ORTHOPEDIC CORP.
9110-8104 / 9110-810404711605587105
Single use: no
On the market
Conformity Stem 9110-8104-TA
UNITED ORTHOPEDIC CORP.
9110-8104-TA / 9110-8104-TA04719872143116
Single use: no
On the market
Conformity Stem 9110-8301
UNITED ORTHOPEDIC CORP.
9110-8301 / 9110-830104719872145332
Single use: no
On the market
Conformity Stem 9110-8301-RK
UNITED ORTHOPEDIC CORP.
9110-8301-RK / 9110-8301-RK04719886904024
Single use: no
On the market
Conformity Stem 9110-8301-RT
UNITED ORTHOPEDIC CORP.
9110-8301-RT / 9110-8301-RT04719886905533
Single use: no
On the market
Conformity Stem 9110-8302
UNITED ORTHOPEDIC CORP.
9110-8302 / 9110-830204719872145349
Single use: no
On the market
Conformity Stem 9110-8302-RK
UNITED ORTHOPEDIC CORP.
9110-8302-RK / 9110-8302-RK04719886904031
Single use: no
On the market
Conformity Stem 9110-8303
UNITED ORTHOPEDIC CORP.
9110-8303 / 9110-830304719872145356
Single use: no
On the market
Conformity Stem 9110-8303-RK
UNITED ORTHOPEDIC CORP.
9110-8303-RK / 9110-8303-RK04719886904048
Single use: no
On the market
Conformity Stem 9110-8304
UNITED ORTHOPEDIC CORP.
9110-8304 / 9110-830404719872145363
Single use: no
On the market
Conformity Stem 9110-8304-RK
UNITED ORTHOPEDIC CORP.
9110-8304-RK / 9110-8304-RK04719886904055
Single use: no
On the market
Conformity Stem 9110-8305
UNITED ORTHOPEDIC CORP.
9110-8305 / 9110-830504719872145608
Single use: no
On the market
Conformity Stem 9110-8305-RK
UNITED ORTHOPEDIC CORP.
9110-8305-RK / 9110-8305-RK04719886904062
Single use: no
On the market
Conformity Stem 9110-8306-RK
UNITED ORTHOPEDIC CORP.
9110-8306-RK / 9110-8306-RK04719886904079
Single use: no
On the market
Conformity Stem 9110-8316
UNITED ORTHOPEDIC CORP.
9110-8316 / 9110-831604719886904284
Single use: no
On the market
United Hip System 1110-7001
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-700104711605583565
Single use: yes
On the market
United Hip System 1110-7002
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-700204711605583572
Single use: yes
On the market
United Hip System 1110-7003
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-700304711605583589
Single use: yes
On the market
United Hip System 1110-7004
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-700404711605583596
Single use: yes
On the market
United Hip System 1110-7005
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-700504711605583602
Single use: yes
On the market
United Hip System 1110-7006
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-700604711605583619
Single use: yes
On the market
United Hip System 1110-7008
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-700804711605583633
Single use: yes
On the market
United Hip System 1110-7010
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-701004711605583657
Single use: yes
On the market
United Hip System 1110-7202
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-720204711605583671
Single use: yes
On the market
United Hip System 1110-7203
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-720304711605583688
Single use: yes
On the market
United Hip System 1110-7204
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-720404711605583695
Single use: yes
On the market
United Hip System 1110-7207
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-720704711605583725
Single use: yes
On the market
United Hip System 1110-7208
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-720804711605583732
Single use: yes
On the market
United Hip System 1110-7210
UNITED ORTHOPEDIC CORP.
1110-7001 / 1110-721004711605583756
Single use: yes
On the market

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