FDA product code · Orthopedic · Class 2
MBI: Fastener, Fixation, Nondegradable, Soft Tissue
MBI is FDA's product code for "Fastener, Fixation, Nondegradable, Soft Tissue": a Class 2 device classified under 21 CFR 888.3040, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for MBI
Across 248 510(k) clearances under MBI decided from 2018-01-01 to 2026-10-06, the median was 74 days from FDA receipt to decision. Half took between 30 and 123 days, and 80% were decided within 158 days. These are past clearances, not a forecast for a new submission.
| Fastest | 7 |
|---|---|
| 25th percentile | 30 |
| Median | 74 |
| 75th percentile | 123 |
| 80th percentile | 158 |
| 90th percentile | 260 |
| Slowest | 448 |
| Year | Median days | n |
|---|---|---|
| 2018 | 91 | 16 |
| 2019 | 90 | 31 |
| 2020 | 83 | 35 |
| 2021 | 107 | 18 |
| 2022 | 64 | 19 |
| 2023 | 57 | 52 |
| 2024 | 30 | 22 |
| 2025 | 58 | 27 |
| 2026 (to 10-06, partial) | 63 | 28 |
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.
MBI in the public FDA record
| 510(k) clearances, all years | 603 |
|---|---|
| Device recalls | 113 |
| Establishment listings | 2,386 |
| GUDID device identifiers | 4,740 |
Counts of records, not of devices or events. Adverse event reports for MBI 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 MBI
14 FDA recognized consensus standards cite MBI, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F1839-08 (Reapproved 2021). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-242 ASTM F1839-08 (Reapproved 2021) — Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
- 11-419 ASTM F3690-24 — Standard Test Method for Evaluating Suture Anchor Insertion and Pull Displacement Resistance
- 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 8-495 ISO 5834-3 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
- 8-496 ISO 5834-4 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
- 8-497 ISO 5834-5 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
- 8-501 ISO 5834-1 Fourth edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
- 8-514 ISO 5834-2 Fifth edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
- 8-558 ASTM F3333-20 — Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 8-572 ASTM F2565-21 — Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
- 8-573 ASTM F2695-12(2025) — Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.