ARBOR External Fixation System
FDA 510(k) clearance K172438 · decided 2018-01-12
Clearance details
- K-number
- K172438
- Device name
- ARBOR External Fixation System
- Applicant
- Globus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-11
- Decision date
- 2018-01-12
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Audubon, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (K254087) | Synthes (USA) Products, LLC | 2026-06-11 |
| DYNEX® External Fixation Systems (K260900) | Vilex, LLC | 2026-04-17 |
| QuikFix External Fixator: Knee-Spanning Pack (K260112) | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| Excelsior System (K253291) | Blue Ocean Global | 2026-01-20 |
| Hoffmann LRF System (K253202) | Stryker GmbH | 2025-12-19 |
| Monkey Rings External Ring Fixation System (K253613) | Paragon 28, Inc. | 2025-12-19 |
| Medusa Orthopedics Boa External Fixation System (K252555) | Medusa Orthopedics, LLC | 2025-11-25 |
| The Response Ortho Smart Fixator - Hexapod System (K252625) | Response Ortho Solutions, LLC | 2025-11-20 |
| External Fixation Mini Rail System (K252106) | Paragon 28, Inc. | 2025-09-30 |
| External Fixation Bone Distractor (K251862) | Paragon 28, Inc. | 2025-08-11 |
| SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K250472) | Amdt Holdings, Inc. | 2025-08-08 |
| Extremity Medical External Fixation System (K251128) | Extremity Medical, LLC | 2025-05-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SECURE®-C Cervical Artificial Disc (P100003/S008) | Globus Medical, Inc. | 2023-06-12 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007) | Globus Medical, Inc. | 2017-08-18 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006) | Globus Medical, Inc. | 2016-05-17 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005) | Globus Medical, Inc. | 2014-12-18 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S004) | Globus Medical, Inc. | 2014-06-30 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S003) | Globus Medical, Inc. | 2014-05-08 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S002) | Globus Medical, Inc. | 2013-09-06 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001) | Globus Medical, Inc. | 2013-03-15 |