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Apollo Knee TKR.IN.1850

by Corin Ltd

Ref TKR.KT.1300Model Apollo Knee

Apollo Knee TKR.IN.1850 is a device classified as Class I in the EU and Class II in the US made by Corin Ltd, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 50553438INSTRAPLMRK1SLB), cleared under FDA 510(k) K231172 on 26 Jul 2023 and listed in FDA GUDID since 7 Apr 2025 (UDI-DI 05056139246715), active as of 22 Oct 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231172

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number50553438INSTRAPLMRK1SLB Basic UDI-DI 05056139246715UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056139246715 UDI-DI Date7 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231172 Date26 Jul 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 50553438INSTRAPLMRK1SLB registered 23 Sep 2026 Active
  • FDA 510(k) K231172 decided 26 Jul 2023 Active
  • FDA GUDID UDI-DI 05056139246715 listed 7 Apr 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231172
  2. Listed FDA GUDID 05056139246715
  3. Registered EUDAMED 50553438INSTRAPLMRK1SLB

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  • Withdrawn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
Apollo Tracker and Pin Kit EUDAMED
Apollo Knee GUDID
Generic name
Robotic surgical telemanipulation system
Device name
Apollo Sterile Markers
Model / reference
Apollo Knee EUDAMED
TKR.KT.1300 EUDAMED
TKR.IN.1850 GUDID
Primary DI / UDI-DI
05056139246715
Basic UDI-DI
50553438INSTRAPLMRK1SLB
510(k) Number
FDA product code
OLO
EMDN code
Z12130485 Stereotactic orthopaedic surgery instruments - consumables
GMDN term
Robotic surgical telemanipulation system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Apollo Knee
TKR.KT.1300
GUDID
TKR.IN.1850
Device classEUDAMED
Class I
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 05056139246715: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 05056139246715: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class I 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: Robotic surgical arm system

Cleared under the same submission (K231172)

and 8 more cleared under K231172

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES.

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)