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Juniortho Plating System 1

by Orthofix SRL 352 variants

Part of a family of 139 devices: see the family page

Ref 99-5453542Model OSTEOSYNTHESIS SCREW-PLATE SYSTEMS

Juniortho Plating System 1 (99-5453542) is an orthopaedic bone screw (EU MDR Class IIb; FDA Class II; FDA product code HWC, Screw, Fixation, Bone) made by Orthofix SRL, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436StInScrw2bN27SY), cleared under FDA 510(k) K213572 on 18 Jan 2022 and listed in FDA GUDID since 31 Mar 2022 (UDI-DI 18052469475386), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213572

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436StInScrw2bN27SY Basic UDI-DI 18052469475386UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18052469475386 UDI-DI Date31 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213572 Date18 Jan 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436StInScrw2bN27SY registered 22 Oct 2026 Active
  • FDA 510(k) K213572 decided 18 Jan 2022 Active
  • FDA GUDID UDI-DI 18052469475386 listed 31 Mar 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213572
  2. Listed FDA GUDID 18052469475386
  3. Registered EUDAMED 805050436StInScrw2bN27SY

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
JPS JuniOrtho Plating System EUDAMED
Juniortho Plating System GUDID
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Model / Ref / Catalog
OSTEOSYNTHESIS SCREW-PLATE SYSTEMS, 99-5453542, 1
Primary DI / UDI-DI
18052469475386
Basic UDI-DI
805050436StInScrw2bN27SY
510(k) Number
FDA product code
HWC
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 3.5 Millimeter
Length — 42 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
OSTEOSYNTHESIS SCREW-PLATE SYSTEMS
99-5453542
GUDID
1
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K213572)

and 8 more cleared under K213572

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)