510(k) clearances

ATTUNE Revision Knee System

Depuy Orthopaedics, Inc. · Orthopedic

K262130Substantially EquivalentTraditionalJWH
Open FDA's page for this record
Third party flag
N
City
Warsaw
Advisory committee description
Orthopedic
Address 1
700 Orthopaedic Dr.
Statement or summary
Summary
Product code
JWH
Zip code
46582
Applicant
Depuy Orthopaedics, Inc.
Decision date
2026-09-04
Decision code
SESE
Country code
US
Device name
ATTUNE Revision Knee System
Advisory committee
OR
Contact
Christina Kaucic
K number
K262130
State
IN
Date received
2026-06-24
Review advisory committee
OR
Postal code
46582
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medical specialty description
Orthopedic
Regulation number
888.3560
Device class
2
Registration number
2249615, 3012392319, 3014273644, 3013176080, 3006849754, 3013843055, 3026771806, 3010057495, 3010468876, 3010386387, 3012523063, 3010123256, 3008285983, 3009998573, 3003916006, 3003387384, 3004450489, 3019006180, 3015167917, 3016096064, 3008021110, 3015542154, 1724955, 1000200989, 3005596372, 3009882462, 2648920, 3005874553, 2531477, 3011187779, 2183744, 3006395932, 3002806603, 3008102042, 1423662, 3007963827, 3003541440, 3007334927, 3000236920, 3006694268 +280 more
FEI number
3012392319, 3014273644, 3013176080, 3003714383, 3006849754, 3013843055, 1000116116, 3026771806, 3010057495, 3010386387, 3012523063, 3010123256, 3008285983, 3002459190, 3002807113, 3009998573, 3003916006, 3003387384, 3004450489, 3003110073, 1000115656, 3019006180, 3015167917, 3016096064, 3000215273, 3008021110, 3015542154, 3003142829, 1000200989, 3005596372, 3009882462, 3005874553, 3000205591, 3011187779, 2183744, 3006395932, 3002806603, 3007963827, 3002806534, 3003541440 +280 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.