ClearanceBrief
Company · US

Exactech, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2026. Name variants (Inc, Corp, punctuation) are merged.

186510(k) clearances (2 in 12 months)
221recalls (5 in 12 months)
184recalls that name a 510(k)

Product codes

CodeDeviceRecords
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer96
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented45
PHXShoulder Prosthesis, Reverse Configuration44
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented36
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented31
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented15
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate11
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer9
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented9
HTWBit, Drill6
HTXRongeur6
MQVFiller, Bone Void, Calcium Compound6
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented6
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented5
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer5
LODBone Cement5
LXHOrthopedic Manual Surgical Instrument5
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer5
HWAImpactor4
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented4

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 14, 2026K260583Equinoxe® Shoulder System
Exactech, Inc.
PHX
Dec 1, 2025K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
Exactech, Inc.
KWT
Aug 1, 2025K243448Equinoxe® Shoulder System
Exactech, Inc.
PHX
Jun 26, 2025K243275Equinoxe® Scapula Fracture System
Exactech, Inc.
HRS
Mar 10, 2025K243839Alteon® HA Femoral Stems
Exactech, Inc.
MEH
Oct 3, 2024K240393Exactech® TRULIANT® Knee System
Exactech, Inc.
MBH
Jul 18, 2024K233482Equinoxe® Central Screw Baseplate System
Exactech, Inc.
PHX
Oct 12, 2023K230717Exactech® Vantage® Total Ankle System
Exactech, Inc.
HSN
Sep 25, 2023K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
Exactech, Inc.
HRS
Sep 14, 2023K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
Exactech, Inc.
PHX
Sep 11, 2023K232002Vantage® Total Ankle System
Exactech, Inc.
HSN
Jul 17, 2023K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
Exactech, Inc.
JWH
May 19, 2023K221323Exactech® Alteon® Short Tapered Wedge
Exactech, Inc.
LZO
Mar 4, 2022K212356Exactech® Equinoxe® Laser Cage Glenoid
Exactech, Inc.
KWS
Apr 29, 2020K192097Exactech® Equinoxe® Stemless Humeral Components
Exactech, Inc.
PKC
Feb 20, 2020K193098Exactech® Equinoxe® Reverse Shoulder Glenospheres
Exactech, Inc.
PHX
Oct 22, 2019K190890Exactech Alteon Modular Dual Mobility (MDM) System
Exactech, Inc.
LZO
Aug 20, 2019K191561Exactech Equinoxe Humeral Augmented Trays
Exactech, Inc.
PHX
Apr 1, 2019K183343Vantage Total Ankle Flat Cut Talar Components
Exactech, Inc.
HSN
Mar 13, 2019K182502Alteon Acetabular Cup System
Exactech, Inc.
LPH
Nov 26, 2018K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
Exactech, Inc.
MBH
Nov 8, 2018K182462Exactech Alteon Highly Polished Femoral Stem
Exactech, Inc.
LZO
Oct 12, 2018K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equ
Exactech, Inc.
PHX
Sep 28, 2018K181794Truliant Porous Femoral Components
Exactech, Inc.
MBH
Sep 4, 2018K181532Exactech Alteon Monobloc Revision Stem
Exactech, Inc.
LZO
Jul 25, 2018K180632Exactech Equinoxe Small Reverse Shoulder System
Exactech, Inc.
PHX
Mar 12, 2018K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
Exactech, Inc.
OQI
Mar 9, 2018K173388Exactech Equinoxe Stemless Shoulder
Exactech, Inc.
PKC
Apr 28, 2017K171045Exactech® Truliant™ Line Extensions
Exactech, Inc.
JWH
Apr 26, 2017K162732Exactech® Alteon® HA Femoral Stem
Exactech, Inc.
MEH
Mar 6, 2017K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe
Exactech, Inc.
PHX
Feb 27, 2017K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
Exactech, Inc.
KWT
Feb 23, 2017K170240Truliant Femoral Components
Exactech, Inc.
JWH
Feb 1, 2017K162726Exactech® Equinoxe® Preserve Stem
Exactech, Inc.
PHX
Aug 31, 2016K153649Exactech® Novation® Element Press-fit Femoral Stem
Exactech, Inc.
MEH
Jun 28, 2016K160697Gibralt® Spine System and Gibralt® Occipital Spine System
Exactech, Inc.
NKG
Mar 25, 2016K153595Optetrak Logic Metaphyseal Cones
Exactech, Inc.
JWH
Mar 18, 2016K160484Optetrak Advanced Patella
Exactech, Inc.
JWH
Mar 10, 2016K153776Optetrak One Logic Femoral Components
Exactech, Inc.
MBH
Mar 10, 2016K152217Exactech Vantage Total Ankle System
Exactech, Inc.
HSN
Sep 3, 2015K152170Exactech Optetrak Logic Enhanced Assembly
Exactech, Inc.
JWH
Sep 3, 2015K141960Exactech® Novation® Crown Cup®
Exactech, Inc.
LPH
Jul 20, 2015K150066Exactech Alteon Monobloc Revision Stem
Exactech, Inc.
LZO
May 29, 2015K150890Exactech Optetrak Logic CC
Exactech, Inc.
JWH
May 28, 2015K150130Ascendant TM Cervical Spacer System
Exactech, Inc.
ODP
May 14, 2015K150458Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
Exactech, Inc.
PHX
May 11, 2015K150152The Octane Straight Intervertebral Fusion Device, Ti Coated
Exactech, Inc.
MAX
Apr 9, 2015K143659Equinoxe Mega Prosthesis
Exactech, Inc.
KWT
Feb 27, 2015K143576Exactech Ambassador
Exactech, Inc.
KWQ
Aug 28, 2014K141821ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET
Exactech, Inc.
LZO

Newest 50 of 186.

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 9, 2026Exactech, Inc.
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Open, Classified
HWANone listed
Mar 9, 2026Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Open, Classified
HWANone listed
Nov 17, 2025Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a componen
Open, Classified
PHXK042021
Nov 17, 2025Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
Open, Classified
PHXK042021
Nov 17, 2025Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Open, Classified
PHXK042021
Sep 12, 2025Exactech, Inc.
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-4
Open, Classified
PHXK223833
Sep 12, 2025Exactech, Inc.
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE
Open, Classified
PHXK063569
Feb 12, 2025Exactech, Inc.
Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHX
Open, Classified
LPHK182502
Feb 12, 2025Exactech, Inc.
Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EH
Open, Classified
OQIK173583
Feb 12, 2025Exactech, Inc.
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 LNR G 32MM 140-32-28 AM EHXL 0 LNR H 32MM 140-28-29 AM EHXL 0 LNR J 28MM 140-32-29 AM EHXL 0 LNR J 32
Open, Classified
OQIK173583
Jun 28, 2024Exactech, Inc.
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 1
Open, Classified
KWYK013211
Jun 18, 2024Exactech, Inc.
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
Open, Classified
JWHK160484
K932690 +1
Jun 18, 2024Exactech, Inc.
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Open, Classified
JWHK160484
K932690 +1
Jun 18, 2024Exactech, Inc.
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
Open, Classified
JWHK160484
K932690 +1
Jun 18, 2024Exactech, Inc.
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
Open, Classified
JWHK160484
K932690 +1
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Open, Classified
PHXK180632
K182536
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
Open, Classified
PHXK180632
K182536
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
Open, Classified
PHXK093275
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
Open, Classified
PHXK093275
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44,
Open, Classified
KWSK113309
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 4
Open, Classified
KWSK113309
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra
Open, Classified
KWSK113309
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Larg
Open, Classified
KWSK113309
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Numbe
Open, Classified
KWSK121220
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number
Open, Classified
KWSK121220
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Numbe
Open, Classified
KWSK111379
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number
Open, Classified
KWSK111379
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33,
Open, Classified
KWSK103419
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c
Open, Classified
KWSK103419
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large,
Open, Classified
KWSK042021
K093430
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shou
Open, Classified
KWSK042021
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shou
Open, Classified
KWSK042021
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Sh
Open, Classified
KWSK042021
Jan 18, 2024Exactech, Inc.
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
Open, Classified
NTGNone listed
Jan 18, 2024Exactech, Inc.
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
Open, Classified
HSNK152217
Jan 18, 2024Exactech, Inc.
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519,
Open, Classified
JWHK223252
Jan 18, 2024Exactech, Inc.
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-
Open, Classified
JWHK152170
K171045
Jan 18, 2024Exactech, Inc.
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Open, Classified
JWHK033883
Jan 18, 2024Exactech, Inc.
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
Open, Classified
JWHK111400
K150890
Jan 18, 2024Exactech, Inc.
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35,
Open, Classified
JWHK160484
K932690 +2
Jan 18, 2024Exactech, Inc.
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Open, Classified
KWZK071676
Jan 18, 2024Exactech, Inc.
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-3
Open, Classified
KWSK212356
Jan 18, 2024Exactech, Inc.
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j)
Open, Classified
KWTK063569
K093275 +2
Jan 18, 2024Exactech, Inc.
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Open, Classified
LPHK182502

Newest 50 of 221.

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