FDA product code · Orthopedic · Class 2
OWI: Bone Fixation Cerclage, Sublaminar
OWI is FDA's product code for "Bone Fixation Cerclage, Sublaminar": a Class 2 device classified under 21 CFR 888.3010, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for OWI
Across 16 510(k) clearances under OWI decided from 2018-01-01 to 2026-10-06, the median was 74 days from FDA receipt to decision. Half took between 51 and 148 days, and 80% were decided within 170 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 51 |
| Median | 74 |
| 75th percentile | 148 |
| 80th percentile | 170 |
| 90th percentile | 225 |
| Slowest | 290 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
OWI in the public FDA record
| 510(k) clearances, all years | 37 |
|---|---|
| Establishment listings | 133 |
Counts of records, not of devices or events. Adverse event reports for OWI are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite OWI
2 FDA recognized consensus standards cite OWI, among them ASTM F2180-17; ASTM F2180-24. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-329 ASTM F2180-17 — Standard Specification for Metallic Implantable Strands and Cables
- 11-432 ASTM F2180-24 — Standard Specification for Metallic Implantable Strands and Cables
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.