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2021 Medical Device Regulation (MDR) Technical Documentation

This page includes all Medical Device Regulation (MDR) Technical Documentation . Please ensure you reference the table below to download the correct documentation in the language you need. 

Pack 1

Iso 639 Lang
EN English
FR French
DE German
IT Italian
ES Spanish
NL Dutch
PL Polish
PT Portuguese
CS Czech

Pack 2

Iso 639 Lang
EN English
SL Slovenian
BG Bulgarian
HR Croatian
SK Slovakian
HU Hungarian
EL Greek
LV Latvian
LT Lithuanian
ET Estonian

Pack 3

Iso 639 Lang
EN English
DA Danish
NO Norwegian
FI Finnish
SV Swedish
RU Russian
ZH Chinese
AR Arabic

Feet

Product Instructions for use Clinician Manual User Guide
Elan Pk1 Pk3 Pk1 Pk3
ElanIC Pk1 Pk3 Pk1 Pk3
Echelon Pk1 Pk2 Pk3 Pk1 Pk2 Pk3
EchelonVT Pk1 Pk2 Pk3 Pk1 Pk2 Pk3
EchelonVAC Pk1 Pk2 Pk3 Pk1 Pk2 Pk3
EchelonER Pk1 Pk2 Pk3 Pk1 Pk2 Pk3
AvalonK2 Pk1 Pk2 Pk3 Pk1 Pk2 Pk3
Esprit Pk1 Pk2 Pk3 Pk1 Pk2 Pk3
Elite2 Pk1 Pk2 Pk3
Multiflex Foot Standard & Slim Pk1
Multiflex Ankle 30mm Clamp Pk1
Multiflex Pyramid Ankle Pk1
SuperSACH Pk1
Epirus Pk1
Elite Blade Pk1
Javelin Pk1

Knees

Product Instructions for use Clinician Manual User Guide
Orion 3 PK1 PK3 PK1 PK3
Mercury Pk1 Pk2 Pk3 Pk1
KX06V2 Pk1 Pk2 Pk3 Pk1 Pk2 Pk3
ESK + Stanceflex Pk1
ESK + 4-Bolt Pk1
ESK + Manual Knee Lock Pk1

Accessories

Product Instructions for use Clinician Manual User Guide
TT Pro Pk1

Children

Product Instructions for use Clinician Manual User Guide
Mini BladeXT Pk1 Pk1

Integrated Limb

Product Instructions for use Clinician Manual User Guide
LinxV2 Pk1 Pk3 Pk1 Pk3

Liners

Product Instructions for use Clinician Manual User Guide
Soft Silicone Liner, Silcare Walk Cushion and Locking Pk1 Pk1
Soft Silicone Liner, Silcare Breathe Walk Cushion and Locking Pk1 Pk1
Comfort Cushion and Locking Liner Pk1 Pk1
Silcare Breathe Cushion Liner Pk1 Pk1
Silcare Breathe Locking Liner Pk1 Pk1

Adapters

Product Instructions for use Part Number(s)
One Shot Socket (Male) Pk1 Pk2 Pk3
One Shot Socket (Female) Pk1
30mm Long Stump Adapter Pk1 339240
Pyramid Socket Adapter Pk1 189610
Child's Transfemoral Standard Alignment Kit Pk1 Pk2 Pk3 189226
Child's System 3 Prong Lamination Adapter Pk1 Pk2 Pk3 189126
Sliding/Rotating Female Pyramid Pk1 Pk2 Pk3 EP-FSR
Child's system M30 for Child's Knee Pk1 Pk2 Pk3 189726
Sliding Male Pyramid Kit Pk1 Pk2 Pk3 169407
Child's System Female Mini Pyramid Pylon 25mm Pk1 Pk2 Pk3 409099
Pylon Adapter Pyramid Female Ø30mm Pk1 Pk2 Pk3 409053
Sliding/Rotating Male Pyramid Pk1 Pk2 Pk3 EP-MSR
30mm x 250mm Carbon Fiber Tube Pk1 Pk2 Pk3 330146
Female Pyramid Adapter Bonded, 30mm Tube Pk1 Pk2 Pk3 739052, 739053, 739054
Female Shifting Pyramid Pk1 Pk2 Pk3 189128
Tube Clamp Adapter with Female Pyramid, 30mm Pk1 Pk2 Pk3 AK30M1
Female Pyramid Shifting Adapter Short Pk1 409041
BK Top Housing Pk1 339008
Female Pyramid Socket Adapter Pk1 P409049, P409050
Minimum Built Height Full Alignment Kit Pk1 239032
Stainless Steel Pyramid 4-Bolt Adapter (Male) P189310
Dynamic Pylon Top Housing Pk1 539601, 539602
Full Alignment Kit Pk1 189806, 189805, 189807 189906
Carbon Fiber Tube 025 mm & 030 mm Pk1 330120, 330132, 330137
Aluminum Tube 030 mm Pk1 903220/200—200 mm long, 903220/400—400 mm long, 903220/500—500 mm long
M30 Mini BladeXT Adapter Pk1 189826
Child’s M30 4-Prong Laminate Adapter Pk1 189626
M36 Adapter Kit Pk1 239092
Proximal Pyramid Adapter Kit Pk1 239017, 239089
Transfemoral Suction Socket Valve Kit for Flexible Sockets Pk1 099135

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For discontinued products, please see our Product Notices page for technical documentation.