Atlas FDA

Optetrak Advanced Patella

FDA 510(k) clearance K160484 · decided 2016-03-18

Clearance details

K-number
K160484
Device name
Optetrak Advanced Patella
Applicant
Exactech, Inc.
Decision
Substantially Equivalent
Date received
2016-02-22
Decision date
2016-03-18
Days to decision
25 days
Clearance type
Special
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Gainesville, FL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Exactech

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Freedom Total Knee System (E-Poly Tibial Liners) (K261563)Maxx Orthopedics, Inc.2026-08-07
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) (K262251)Globus Medical, Inc.2026-07-31
Klassic Infection Spacer System (K261734)Total Joint Orthopedics, Inc.2026-07-23
ATTUNE Total Knee System; ATTUNE Cementless Knee System (K261458)DePuy Ireland UC2026-06-25
NovoKnee (SteriKnee) (K261032)NovoSource2026-04-27
Materialise TKA Guide System (K253793)Materialise NV2026-01-06
EMPOWR Knee (K252974)Encore Medical L.P.2025-12-19
ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (K253197)Depuy Ireland UC2025-11-19
Freedom Infinia™ Total Knee System (K253314)Maxx Orthopedics, Inc.2025-10-29
Freedom® Total Knee System – Titan PCK Components (K253144)Maxx Orthopedics, Inc.2025-10-22
Stem Extension Line (U2 Total Knee System—PSA Type) (K252725)United Orthopedic Corporation2025-09-25
Materialise TKA Guide System (K251554)Materialise NV2025-07-14

Recalls involving this device

RecordFirmDate
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-0 recall (Z-2155-2024)Exactech, Inc.2024-06-18
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03 recall (Z-2156-2024)Exactech, Inc.2024-06-18
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29 recall (Z-2157-2024)Exactech, Inc.2024-06-18
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, recall (Z-2158-2024)Exactech, Inc.2024-06-18
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, recall (Z-0582-2024)Exactech, Inc.2024-01-18

PMA approvals by this applicant

RecordFirmDate
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S021)Exactech, Inc.2017-04-03
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S020)Exactech, Inc.2016-09-28
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S019)Exactech, Inc.2016-07-21
NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S017)Exactech, Inc.2016-04-26
NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S018)Exactech, Inc.2015-12-30
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S016)Exactech, Inc.2014-06-18
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S015)Exactech, Inc.2013-02-07
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S014)Exactech, Inc.2012-12-05