Skip to content

Ortopro

by Ortopro Tib. Aletler San. Ve Ti̇c. A.Ş. Esb Şubesi̇ 29 variants

Ref 28.2831, 64.3201, 10.1007, 10.1008, 11.1731, 95.0234, 95.0231, 10.2007, 12.0244, 10.9001, 99.0843, 10.9002, 11.1701, 12.0245, 17.5055N, 64.3202, 12.0236, 62.1032, 11.9718, 08.0733, 95.0427, 95.0236, 10.1002, 62.1062, 15.0140, 10.1001, 15.0438, 17.6502N, 99.0844, 28.2800, 10.2008, 64.3001, 15.0138, 99.0840, 17.5050N, 62.1031, 95.0228, 10.7102, 11.1730, 99.0841, 12.0205, 17.8001, 64.3012, 11.9737, 28.0138, 17.8002, 95.0994

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08698850067186 Basic UDI-DI Date30 Nov 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Ceramic Modular Head Ø28 S
SUPERICA KNEE TIBIAL COMPONENT CEMENTED (CoCr) SIZE 1
Troya Cementless Pressfit Stem Size-7
Troya Cementless Pressfit Stem Size-8
INTEGRO NECK NEUTRAL LONG (Co.Cr.Mo)
Troya Broach Size-14
Troya Broach Size-11
Troya Cementless Ha Coated Stem Size-7
Ancale Cr Tibial Insert Size 1-9 Mm
TROYA CEMENTED STEM POLISHED CoCr SIZE-8
65mm COMBINED CUTTER GUIDE
TROYA CEMENTED STEM POLISHED CoCr SIZE-9
Integro Cementless Proximal Body Sandblasted Small
Ancale Cr Tibial Insert Size 1-11 Mm
ST.LEGER NEO KNEE C/R FEMORAL COMPONENT CEMENTED LEFT 55mm
SUPERICA KNEE TIBIAL COMPONENT CEMENTED (CoCr) SIZE 2
Ancale Tibial Component Cemented Size 1
Paragon Standard Ha Coated Stem SIZE2
Reflecto Femoral Component Cemented Left Size 1
Troya Broach Size-13
Distal Tapered Reamer Size 7-8-9
Troy Broach Size-16
BONE PLUG 11mm
Paragon Standard Porous+ha Coated Stem SIZE2
BIPOLAR SHELL WITH INSERT (SS) Ø40mm
BONE PLUG 10mm
BIPOLAR SHELL WITH INSERT (CoCr) Ø38mm
ST.LEGER NEO C/R TIBIAL INSERT 50mm 9mm
70mm COMBINED CUTTER GUIDE
Xl-Uhmwpe Acetabular Liner 0 Deg. Ø 22 for Size 38-40 (Group 0)
Troya Cementless Ha Coated Stem Size-8
Superica Knee Femoral Component Cemented Left Size 1
BIPOLAR SHELL WITH INSERT (SS) Ø38mm
50mm COMBINED CUTTER GUIDE
ST.LEGER NEO KNEE C/R FEMORAL COMPONENT CEMENTED LEFT 50mm
Paragon Standard Ha Coated Stem SIZE1
Troya Broach Size-8
Distal Centraliser Size-9
INTEGRO NECK NEUTRAL SHORT (Co.Cr.Mo)
55mm COMBINED CUTTER GUIDE
Ancale Cr Femoral Component Cemented Left Size 2
ST.LEGER NEO PATELLAR COMPONENT 29mm
Superica Knee Tibial Insert Left 12mm Size 1
Reflecto Tibial Insert Size 1 X 11 Mm
HIPEX Ti PLASMA ACETABULAR SHELL CEMENTLESS SIZE 38
ST.LEGER NEO PATELLAR COMPONENT 32mm
Stem Inserter Threaded
Model / Reference
28.2831, 64.3201, 10.1007, 10.1008, 11.1731, 95.0234, 95.0231, 10.2007, 12.0244, 10.9001, 99.0843, 10.9002, 11.1701, 12.0245, 17.5055N, 64.3202, 12.0236, 62.1032, 11.9718, 08.0733, 95.0427, 95.0236, 10.1002, 62.1062, 15.0140, 10.1001, 15.0438, 17.6502N, 99.0844, 28.2800, 10.2008, 64.3001, 15.0138, 99.0840, 17.5050N, 62.1031, 95.0228, 10.7102, 11.1730, 99.0841, 12.0205, 17.8001, 64.3012, 11.9737, 28.0138, 17.8002, 95.0994
Primary DI / UDI-DI
08698850067186, 08698850179070, 08698850000558, 08698850000565, 08698850182971, 08698850191942, 08698850191911, 08698850000657, 08698850185583, 08698850000015, 08698850197067, 08698850000022, 08698850182742, 08698850185590, 08698850047492, 08698850179087, 08698850185507, 08698850112978, 08698850183190, 08698850191935, 08698850192215, 08698850191966, 08698850000428, 08698850113210, 08698850057927, 08698850000411, 08698850058023, 08698850048116, 08698850197074, 08698850067339, 08698850000664, 08698850178974, 08698850057910, 08698850197036, 08698850047485, 08698850112961, 08698850191881, 08698850000497, 08698850182964, 08698850197043, 08698850185194, 08698850048802, 08698850179186, 08698850183381, 08698850066783, 08698850048819, 08698850191973
Basic UDI-DI
B-08698850067186, B-08698850179070, B-08698850000558, B-08698850000565, B-08698850182971, B-08698850191942, B-08698850191911, B-08698850000657, B-08698850185583, B-08698850000015, B-08698850197067, B-08698850000022, B-08698850182742, B-08698850185590, B-08698850047492, B-08698850179087, B-08698850185507, B-08698850112978, B-08698850183190, B-08698850191935, B-08698850192215, B-08698850191966, B-08698850000428, B-08698850113210, B-08698850057927, B-08698850000411, B-08698850058023, B-08698850048116, B-08698850197074, B-08698850067339, B-08698850000664, B-08698850178974, B-08698850057910, B-08698850197036, B-08698850047485, B-08698850112961, B-08698850191881, B-08698850000497, B-08698850182964, B-08698850197043, B-08698850185194, B-08698850048802, B-08698850179186, B-08698850183381, B-08698850066783, B-08698850048819, B-08698850191973
EMDN Code
P090804050201, P090903020104, P090804010201, P09080407, L091199, P090903020202, P090804010101, P090804030202, P0909030101, P09090501, P09088006, P090804050102, P090803040101, P09088005, P0909070201, P090905020202, P090803010201
Device Class
Class III
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000015164

Other devices from Ortopro Tib. Aletler San. Ve Ti̇c. A.Ş. Esb Şubesi̇

See all devices from Ortopro Tib. Aletler San. Ve Ti̇c. A.Ş. Esb Şubesi̇ →

Properties

  • Sterile YesEUDAMEDNoEUDAMED
  • Implantable YesEUDAMEDNoEUDAMED
  • Reusable NoEUDAMEDYesEUDAMED

Other properties (8)

  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No