FDA.reportPublic FDA data

VersaPEEK

Primary DI
06009712642243
Brand
VersaPEEK
Company
ORTHO-DESIGN (PTY) LTD
Model
APP002
Catalog number
APP002
Device description
VersaPEEK™, PEEK Suture Anchor, 4.5 x 15mm, 2 Sutures
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242296000VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)Ortho-Design (Pty), Ltd.2024-08-29MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009712642243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009712642243060097126422436009712642243

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557386523
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009712642236VersaPEEKAPP001APP0012025-08-11
06009712642267VersaPEEKAPP002-NAPP002-N2025-08-11
06009708899484VersaTiATP004ATP0042023-09-01
06009712641611VersaTiATP001ATP0012023-09-01
06009712641628VersaTiATP002ATP0022023-09-01
06009712641642VersaTapADP005ADP0052023-09-01
06009712641666MiniTiATP003ATP0032023-09-01
06009712642250VersaPEEKAPP001-NAPP001-N2023-09-01
06009712641581VersaTapADP001ADP0012023-08-31
06009712642861VersaTap /VersaLat RecoveryADP003-2ADP003-22024-06-24
06009712642434VersaTap/Lat Removal ToolADP003-1ADP003-12023-09-07
06009712642441VersaTap Tip RemovalADP004-1ADP004-12023-09-07
06009712642663VersaPEEK TapAPP001-1APP001-12023-09-07
06009712642878VersaTap Tip RecoveryADP004-2ADP004-22024-06-24
06009712642885DoubleTapADP009-2ADP009-22024-06-24
06009712642892VersaPEEK Tapping ToolAPP001-2APP001-22024-06-24
06009712642731Anchor Threaded TitaniumATT-2x6 2S NDATT-2x6 2S ND2023-12-07
06009712642748Anchor Threaded TitaniumATT-3x11 2S NATT-3x11 2S N2023-12-07
06009712642755Anchor Threaded TitaniumATT-4x13 2S NATT-4x13 2S N2023-12-07
06009712642762Anchor Threaded TitaniumATT-6x17 2S NATT-6x17 2S N2023-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20845854655501Argo KnotlessConmed CorporationMBI2026-09-25
20845854655518Argo KnotlessConmed CorporationMBI2026-09-25
00889024711280Jgrknt Reusable Fishmouth Perc GuideBiomet Orthopedics, LLCMBI2026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideBiomet Orthopedics, LLCMBI2026-08-25
00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00810146164340RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164357RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164388RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164418RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164449RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164456RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164463RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164500RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164517RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164531RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164562RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164579RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164623RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164654RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164685RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
00860016070004ICONN Revolution 6.5MM Knotless Suture AnchorICONN ORTHOPEDICS LLCMBI2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant SystemT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and InserterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462911VersiTILT 2.4x12mm Button and Inserter, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16