Integra® TruArch®
- Primary DI
- M268TRUARCHIMP1
- Brand
- Integra® TruArch®
- Company
- Ascension Orthopedics, Inc.
- Model
- TRUARCHIMP
- Catalog number
- TRUARCHIMP
- Device description
- The Integra TruArch subtalar implant is a one-piece titanium implant for treating hyperpronation of the foot. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. The implant is offered in 5 sizes ranging from 8mm to 12mm in diameter. The system includes instruments to facilitate the placement of the implants.
- Published
- 2015-09-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Contact Domains#
integralife.comProduct Codes#
| Code | Name |
|---|---|
| HWC | Screw, fixation, bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K111265 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780074342 | Primary | GS1 | 0 | |
| M268TRUARCHIMP1 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780074342 | 10381780074342 |
GMDN Terms#
| Term | Definition |
|---|---|
| Subtalar implant, non-bioabsorbable, sterile | A sterile device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE). |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 942377524
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10381780240204 | Cadence™ | 10203022 | 2016-08-24 | |
| 10381780240211 | Cadence™ | 10203023 | 10203023 | 2016-08-24 |
| 10381780240228 | Cadence™ | 10203024 | 10203024 | 2016-08-24 |
| 10381780240235 | Cadence™ | 10203025 | 2016-08-24 | |
| 10381780240242 | Cadence™ | 10203026 | 2016-08-24 | |
| 10381780240754 | Cadence™ | 10204202 | 10204202 | 2016-08-24 |
| 10381780245612 | Titan™ | IMC096004301 | IMC-0960-043-01 | 2017-08-30 |
| 10381780246374 | Integra® | OSG20000 | OSG-200-00 | 2017-08-30 |
| 10381780246381 | Integra® | OSG20010P | OSG-200-10P | 2017-08-30 |
| 10381780246398 | Integra® | OSG20010PV | OSG-200-10PV | 2017-08-30 |
| 10381780246404 | Integra® | OSG20020P | OSG-200-20P | 2017-08-30 |
| 10381780246411 | Integra® | OSG20020PV | OSG-200-20PV | 2017-08-30 |
| 10381780246428 | Integra® | OSG20030P | OSG-200-30P | 2017-08-30 |
| 10381780246435 | Integra® | OSG20030PV | OSG-200-30PV | 2017-09-05 |
| 10381780246442 | Integra® | OSG20040P | OSG-200-40P | 2017-09-05 |
| 10381780246459 | Integra® | OSG20040PV | OSG-200-40PV | 2017-08-30 |
| 10381780246466 | Integra® | OSG35001 | OSG-350-01 | 2017-08-30 |
| 10381780246473 | Integra® | OSG44200 | OSG-442-00 | 2017-09-05 |
| 10381780246480 | First Choice® DRUJ System | OSG60000 | OSG-600-00 | 2017-09-05 |
| 10381780246497 | First Choice® DRUJ System | OSG60001 | OSG-600-01 | 2017-09-05 |
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