DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc.
DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc. (Georgia): 510(k) cleared for MedShape, Inc. Its amount of 181 is above the median of 138 (64th percentile). Dated 42 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 181 · 64th percentile of 414 FDAPulse records · 1.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 68 related GA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260995 |
| Device | DynaNail Helix® Fixation System |
| Applicant | MedShape, Inc. |
| Specialty / panel | Orthopedic |
| Product code | HWC |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-26 |
| Decision date | 2026-09-23 |
| Review time (days) | 181 |
| Third-party review | No |
| Applicant location | Atlanta, GA, US |
| amount percentile | 64th of 414 (median 138, 1.3x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-23
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc. and 69 Georgia peers
- Georgia FDAPulse records like this one: 69
- DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc.'s amount: 64th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Georgia peer: $13,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 181-day review, longer than typical.
- Posted 42 days ago.
What is the FDAPulse record for DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc. in Georgia?
DynaNail Helix® Fixation System (K260995) by MedShape, Inc. was cleared on 2026-09-23 after 181 days of review.
How does DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc. compare to other Georgia FDAPulse records?
Its amount of 181 sits in the upper half (64th percentile) of 414 records; the median is 138. It is 42 days old, still within a typical 45-day follow-up window.
DynaNail Helix® Fixation System (K260995) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| DynaNail Helix® Fixation System (K260995) | GA | 2026-09-23 |
| TruVision Single-Use 1.9mm Arthroscopy System (K260156) | UT | 2026-10-09 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| F.A.S.T Screw (K254280) | FR | 2026-09-21 |
Related records
- TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC
- Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd.
- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
- The VEGA Cervical Screw System (K254260): 510(k) cleared for GS Medical Co., Ltd.
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- Tempo Plating System (K263407): 510(k) cleared for Pace Surgical
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