FDA.reportPublic FDA data

CyclaPlex Implant

Primary DI
07290017626826
Brand
CyclaPlex Implant
Company
ALPHAMET LTD
Model
V7
Catalog number
IM-9101
Device description
The implant is comprised of two metallic bone screws ("Anchor1", "Anchor 2") connected by an UHMW polyethylene multiple suture cord. The implant device pulls the 1st metatarsal inward, towards the 2nd metatarsal and reduces the intermetatarsal angle to normal medically-accepted values. It is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the first intermetatarsal angle.
Published
2020-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTNWasher, Bolt Nut

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183094000CyclaPlex Correction SystemCycla Orthopedics, Ltd.2019-04-26HTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017626819PackageGS120In Commercial Distribution
07290017626826PackageGS14In Commercial Distribution
07290017626833PackageGS11In Commercial Distribution
07290017626017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017626819072900176268197290017626819
07290017626826072900176268267290017626826
07290017626833072900176268337290017626833
07290017626017072900176260177290017626017

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(260) 438-2198bcoburn@genorthopartners.com

Regulatory Flags#

DUNS number
600372473
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017626017CyclaPlex ImplantV7IM-91012020-02-12
07290017626116CyclaPlex Correction System Instruments CaseV7IC-98012020-02-12
07290017626123CyclaPlex Correction System Instruments Case SetV7IC-98022020-02-12
07290017626161CyclaPlex Drill Bits 1.8-3.0 V7DB-92432020-02-12
07290017626192CyclaPlex Drill GuideV7DG-92012020-02-12
07290017626222CyclaPlex ScrewdriverV7SD-92212020-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QCChest Wall Innovations, Inc.HTN2026-06-01
00850080543108PC Fix Graphic CaseChest Wall Innovations, Inc.HTN2026-06-01
00850080543115PC Fix Clamp/Drill Guide TopChest Wall Innovations, Inc.HTN2026-06-01
00850080543122PC Fix Clamp/Drill Guide BottomChest Wall Innovations, Inc.HTN2026-06-01
00850080543139PC Fix Compression ClampChest Wall Innovations, Inc.HTN2026-06-01
00850080543146PC Fix 3.2mm Drill Dental LatchChest Wall Innovations, Inc.HTN2026-06-01
00850080543184PC Fix Implant CaddyChest Wall Innovations, Inc.HTN2026-06-01
07901125602533Expert KnotlessGM DOS REIS INDUSTRIA E COMERCIO LTDAHTN2026-05-28
00888867251960Arthrex®ARTHREX, INC.HTN2017-11-28
00888867251939Arthrex®ARTHREX, INC.HTN2017-02-15
07613327075830ASNISStryker GmbHHTN2015-11-11
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07613327076301ASNISStryker GmbHHTN2015-11-11
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07613327076721ASNISStryker GmbHHTN2015-11-11
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07613327077049ASNISStryker GmbHHTN2015-11-11
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07613327073768VARIAXStryker GmbHHTN2015-09-30
07613327073799VARIAXStryker GmbHHTN2015-09-30
07613327073812VARIAXStryker GmbHHTN2015-09-30