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 | Language |
|---|---|
| EN | English |
| FR | French |
| DE | German |
| IT | Italian |
| ES | Spanish |
| NL | Dutch |
| PL | Polish |
| PT | Portuguese |
| CS | Czech |
Pack 2
| Iso 639 | Language |
|---|---|
| EN | English |
| SL | Slovenian |
| BG | Bulgarian |
| HR | Croatian |
| SK | Slovakian |
| HU | Hungarian |
| EL | Greek |
| LV | Latvian |
| LT | Lithuanian |
| ET | Estonian |
Pack 3
| Iso 639 | Language |
|---|---|
| EN | English |
| DA | Danish |
| NO | Norwegian |
| FI | Finnish |
| SV | Swedish |
| RU | Russian |
| ZH | Chinese |
| AR | Arabic |
Feet
| Product | Instruction for Use | Clinician's Manual | User Guide |
|---|---|---|---|
| BladeXT | Pk1 | ||
| 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 | ||
| Elite Blade VT | Pk1 Pk2 Pk3 | ||
| Javelin | Pk1 |
Knees
| Product | Instruction for Use | Clinician's Manual | User Guide |
|---|---|---|---|
| Orion 3 | PK1 PK3 | PK1 PK3 | |
| Mercury | Pk1 Pk2 Pk3 | Pk1 Pk2 Pk3 | |
| KX06V2 | Pk1 Pk2 Pk3 | Pk1 Pk2 Pk3 | |
| KX07 | Pk1 | Pk1 | |
| Compact SAKL | Pk1 | ||
| ESK + Stanceflex | Pk1 Pk2 Pk3 | ||
| ESK + 4-Bolt | Pk1 Pk2 Pk3 | ||
| ESK + Manual Knee Lock | Pk1 Pk2 Pk3 |
Accessories
| Product | Instruction for Use | Clinician's Manual | User Guide |
|---|---|---|---|
| TT Pro | Pk1 |
Children
| Product | Instruction for Use | Clinician's Manual | User Guide |
|---|---|---|---|
| Mini BladeXT | Pk1 | Pk1 | |
| 4-Bar Knee | Pk1 |
Integrated Limb
| Product | Instruction for Use | Clinician's Manual | User Guide |
|---|---|---|---|
| LinxV2 | Pk1 Pk3 | Pk1 Pk3 |
Liners
| Product | Instruction for Use | Clinician's 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 | Instruction 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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Canada
India
France
Germany | Deutschland
Norway | Norge
Russia | Россия
United KingdomFor discontinued products, please see our Product Notices page for technical documentation.