FDA.reportPublic FDA data

Monkey Rings™ External Fixation System

Primary DI
00889795152152
Brand
Monkey Rings™ External Fixation System
Company
Paragon 28, Inc.
Model
P45-113-0200
Catalog number
P45-113-0200
Device description
Tibial Ring 200mm, Tabs
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212895000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212895000Paragon 28 External Ring Fixation SystemParagon 28, Inc.2021-11-08KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795152152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795152152008897951521528897951521520889795152152

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system noninvasive component, single-useA noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.

Regulatory Flags#

DUNS number
042961576
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795120199Paragon 28 Bone Wedge SystemAOCWO-16-5AOCWO-16-52023-06-26
00889795120632Paragon 28 Bone Wedge SystemAOLEW-22-12AOLEW-22-122023-04-04
00889795118523Paragon 28 Bone Wedge SystemAOCW-TRL-16-4.5AOCW-TRL-16-4.52022-10-14
00889795118530Paragon 28 Bone Wedge SystemAOCW-TRL-16-5.5AOCW-TRL-16-5.52022-10-14
00889795118547Paragon 28 Bone Wedge SystemAOCW-TRL-16-6.5AOCW-TRL-16-6.52022-10-14
00889795118554Paragon 28 Bone Wedge SystemAOCW-TRL-18-4.5AOCW-TRL-18-4.52022-10-14
00889795118561Paragon 28 Bone Wedge SystemAOCW-TRL-18-5.5AOCW-TRL-18-5.52022-10-14
00889795118578Paragon 28 Bone Wedge SystemAOCW-TRL-18-6.5AOCW-TRL-18-6.52022-10-14
00889795118585Paragon 28 Bone Wedge SystemAOCW-TRL-20-4.5AOCW-TRL-20-4.52022-10-14
00889795118592Paragon 28 Bone Wedge SystemAOCW-TRL-20-5.5AOCW-TRL-20-5.52022-10-14
00889795118608Paragon 28 Bone Wedge SystemAOCW-TRL-20-6.5AOCW-TRL-20-6.52022-10-14
00889795118615Paragon 28 Bone Wedge SystemAOEW-18-8 TRLAOEW-18-8 TRL2022-10-14
00889795118622Paragon 28 Bone Wedge SystemAOEW-18-10 TRLAOEW-18-10 TRL2022-10-14
00889795118639Paragon 28 Bone Wedge SystemAOEW-18-12 TRLAOEW-18-12 TRL2022-10-14
00889795118646Paragon 28 Bone Wedge SystemAOEW-20-8 TRLAOEW-20-8 TRL2022-10-14
00889795118653Paragon 28 Bone Wedge SystemAOEW-20-10 TRLAOEW-20-10 TRL2022-10-14
00889795118660Paragon 28 Bone Wedge SystemAOEW-20-12 TRLAOEW-20-12 TRL2022-10-14
00889795118677Paragon 28 Bone Wedge SystemAOEW-22-8 TRLAOEW-22-8 TRL2022-10-14
00889795118684Paragon 28 Bone Wedge SystemAOEW-22-10 TRLAOEW-22-10 TRL2022-10-14
00889795118691Paragon 28 Bone Wedge SystemAOEW-22-12 TRLAOEW-22-12 TRL2022-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616835HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327616866HOFFMANN LRFStryker GmbHKTT2026-07-21
00889795154620Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154637Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154644Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154651Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
00841132142325eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142905eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142950eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132143025eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
07613327079241HOFFMANNStryker GmbHKTT2018-09-24
07613327079272HOFFMANNStryker GmbHKTT2018-09-24
07613327079333HOFFMANNStryker GmbHKTT2018-09-24
07613327079395HOFFMANNStryker GmbHKTT2018-09-24
07613327079401HOFFMANNStryker GmbHKTT2018-09-24
07613327079449HOFFMANNStryker GmbHKTT2018-09-24
07613327079470HOFFMANNStryker GmbHKTT2018-09-24
07613327079500HOFFMANNStryker GmbHKTT2018-09-24