Atlas FDA

EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT

FDA 510(k) clearance K993736 · decided 2000-01-20

Clearance details

K-number
K993736
Device name
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
Applicant
Exactech, Inc.
Decision
Substantially Equivalent
Date received
1999-11-04
Decision date
2000-01-20
Days to decision
77 days
Clearance type
Traditional
Product code
LPH
Device class
2
Regulation number
888.3358
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Gainesville, FL, 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
TRIVANCE™ Hip Stem (K254043)Globus Medical, Inc.2026-08-04
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iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating (K243192)Nextstep Arthopedix, LLC2026-06-05
Taperloc® Complete Hip Stem (K251270)Biomet, Inc.2026-05-19
G7® Revision Acetabular System (K252623)Zimmer, Inc.2026-02-04
Mpact 3D Metal Implants Extension – DMLS Technology (K251043)Medacta International S.A.2026-01-28
Velora Acetabular System (K252067)Restor3D, Inc.2025-12-05
TaperSet™ Hip System (K252846)Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics2025-11-20
EMPOWR Acetabular® Liner Extension (K251833)Encore Medical L.P.2025-11-12
ArTT Augments and Buttresses and Bone Screws (K251718)Lima Corporate S.P.A.2025-08-29
Stryker and Serf hip devices (K250989)Howmedica Osteonics Corp (Dba Stryker Orthopaedics)2025-07-25
ONVOY™ Acetabular System (K243456)Globus Medical, Inc.2025-06-06

Recalls involving this device

RecordFirmDate
AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Se recall (Z-0916-2007)Exactech, Inc.2007-06-09

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