Atlas FDA

DURACON BASEPLATES

FDA 510(k) clearance K936008 · decided 1995-08-09

Clearance details

K-number
K936008
Device name
DURACON BASEPLATES
Applicant
Howmedica Corp.
Decision
Substantially Equivalent for Some Indications
Date received
1993-12-16
Decision date
1995-08-09
Days to decision
601 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Rutherford, NJ, US
Third-party review
No
Expedited review
No

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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
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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
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031 recall (Z-0914-2024)Howmedica Osteonics Corp.2024-01-31
LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4 recall (Z-0915-2024)Howmedica Osteonics Corp.2024-01-31

PMA approvals by this applicant

RecordFirmDate
SURGICAL SIMPLEX P BONE CEMENT (N17004/S013)Howmedica Corp.2000-12-15
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012)Howmedica Corp.2000-06-20
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011)Howmedica Corp.1998-03-18
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010)Howmedica Corp.1997-11-13
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009)Howmedica Corp.1997-08-08
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008)Howmedica Corp.1996-12-18
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005)Howmedica Corp.1995-11-21
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006)Howmedica Corp.1995-02-24