Actera™ Hip System

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

Conformis Inc.

The following data is part of a premarket notification filed by Conformis Inc. with the FDA for Actera™ Hip System.

Pre-market Notification Details

• Device ID: K221104
• 510k Number: K221104
• Device Name: Actera™ Hip System
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: Conformis Inc. 600 Technology Park Drive, 4th Floor Billerica, MA 01821
• Contact: Mary Kruitwagen
• Correspondent: Mary Kruitwagen; Conformis Inc. 600 Technology Park Drive, 4th Floor Billerica, MA 01821
• Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-04-14
• Decision Date: 2022-08-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810933031428	K221104	000
00810933031602	K221104	000
00810933031619	K221104	000
00810933031688	K221104	000
00810933031695	K221104	000
00810933031701	K221104	000
M572HES03407UH011	K221104	000
M572HES03408UH011	K221104	000
M572HES03408US011	K221104	000
M572HES03409UH011	K221104	000
00810933031596	K221104	000
00810933031589	K221104	000
00810933031572	K221104	000
00810933031459	K221104	000
00810933031466	K221104	000
00810933031473	K221104	000
00810933031480	K221104	000
00810933031497	K221104	000
00810933031503	K221104	000
00810933031510	K221104	000
00810933031527	K221104	000
00810933031565	K221104	000
M572HES03402CH011	K221104	000
M572HES03402UH011	K221104	000
M572HES03405US011	K221104	000
M572HES03406UH011	K221104	000
M572HES03406US011	K221104	000
M572HES03407CH011	K221104	000
M572HES03407CS011	K221104	000
M572HES03407US011	K221104	000
M572HES03408CH011	K221104	000
M572HES03408CS011	K221104	000
M572HES03409CH011	K221104	000
M572HES03405UH011	K221104	000
M572HES03405CS011	K221104	000
M572HES03405CH011	K221104	000
M572HES03402US011	K221104	000
M572HES03403CH011	K221104	000
M572HES03403CS011	K221104	000
M572HES03403UH011	K221104	000
M572HES03403US011	K221104	000
M572HES03404CH011	K221104	000
M572HES03404CS011	K221104	000
M572HES03404UH011	K221104	000
M572HES03404US011	K221104	000
M572HES03402CS011	K221104	000