FDA product code · Orthopedic
MBIFastener, Fixation, Nondegradable, Soft Tissue
Product code MBI covers Fastener, Fixation, Nondegradable, Soft Tissue, a Class II device regulated under 21 CFR 888.3040. FDA has cleared 597 devices in this code, 28 of them in the last 12 months. Median review time across the 597 most recent decisions is 81 days. openFDA lists 113 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3040
- Review panel
- Orthopedic
- Clearances
- 597
What is happening in MBI right now?
MBI (Fastener, Fixation, Nondegradable, Soft Tissue) has three findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0212-2026, Z-2619-2025). 6 first-time filers in the last 12 months, including Ortobio S.A. and ArthroTAK, LLC (K253027, K252635, K251750, K253538, K252664). The code is crowded, scoring 96 of 100 — 145 companies hold a clearance here and 28 arrived in the last 12 months (MBI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0212-2026, Z-2619-2025 |
| New entrant | Worth knowing | K253027, K252635, K251750, K253538, K252664 |
| Crowding | Context | MBI:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in MBI?
FDA has cleared 597 devices under product code MBI since the 510(k) programme began in 1976, 28 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261632 | Thunderbolt System | Responsive Arthroscopy, Inc. | |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. | |
| K260018 | Arthrex FiberButton | Arthrex, Inc. | |
| K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | |
| K261363 | Y-Knotless Flex Anchors | CONMED Corporation | |
| K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. |
How long does FDA review take for MBI?
The median FDA review time for MBI is 81 days, measured across the 597 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MBI?
openFDA lists 113 recall records against product code MBI. A recall record covers one firm's corrective action and may span many device lots.
Z-0212-2026Open, ClassifiedBiomet, Inc.
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Z-2619-2025Open, ClassifiedBiomet, Inc.
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Z-1328-2025Open, ClassifiedStryker Corporation
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
Z-0581-2025Open, ClassifiedSmith & Nephew, Inc.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Z-0518-2024Open, ClassifiedRiverpoint Medical, LLC
Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.
Showing the 5 most recently initiated of 113. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MBI?
MAUDE holds 10,312 adverse-event reports naming product code MBI, 2,668 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MBI unusual?
Every month with enough history behind it falls inside MBI's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 144 | Insufficient history | No expected range — too little history | |
| 121 | Insufficient history | No expected range — too little history | |
| 164 | Insufficient history | No expected range — too little history | |
| 153 | Insufficient history | No expected range — too little history | |
| 217 | Insufficient history | No expected range — too little history | |
| 169 | Insufficient history | No expected range — too little history | |
| 251 | Insufficient history | No expected range — too little history | |
| 189 | Insufficient history | No expected range — too little history | |
| 190 | Insufficient history | No expected range — too little history | |
| 294 | Insufficient history | No expected range — too little history | |
| 244 | Insufficient history | No expected range — too little history | |
| 266 | Insufficient history | No expected range — too little history | |
| 317 | Insufficient history | No expected range — too little history | |
| 591 | Insufficient history | No expected range — too little history | |
| 511 | Insufficient history | No expected range — too little history | |
| 231 | Insufficient history | No expected range — too little history | |
| 195 | Insufficient history | No expected range — too little history | |
| 333 | Insufficient history | No expected range — too little history | |
| 285 | Insufficient history | No expected range — too little history | |
| 209 | Insufficient history | No expected range — too little history | |
| 302 | Insufficient history | No expected range — too little history | |
| 217 | 14–509 | Within expected (14–509) | |
| 244 | 0–435 | Within expected (0–435) | |
| 246 | 8–494 | Within expected (8–494) | |
| 404 | 6–511 | Within expected (6–511) | |
| 303 | 43–530 | Within expected (43–530) | |
| 332 | 102–502 | Within expected (102–502) | |
| 324 | 275–689 | Within expected (275–689) | |
| 321 | 173–483 | Within expected (173–483) | |
| 349 | 200–491 | Within expected (200–491) | |
| 372 | 200–486 | Within expected (200–486) | |
| 243 | 188–445 | Within expected (188–445) | |
| 411 | 193–462 | Within expected (193–462) | |
| 323 | 245–567 | Within expected (245–567) | |
| 400 | 190–456 | Within expected (190–456) | |
| 359 | 229–529 | Within expected (229–529) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in MBI.
Who has entered MBI in the last year?
6 companies filed in MBI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Ortobio S.A. | K253027 | |
| ArthroTAK, LLC | K252635 | |
| Trax Surgical, Inc. | K251750 | |
| Theramicro | K253538 | |
| GM Dos Reis Industria e Comercio Ltda. | K252664 | |
| Suturetech, Inc. | K250095 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in MBI?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MBI?
Across the 597 most recent decisions, these applicants filed most often in MBI.
| Applicant | Recent clearances |
|---|---|
| Arthrex, Inc. | 52 |
| Innovasive Devices, Inc. | 22 |
| Parcus Medical, LLC | 21 |
| Smith & Nephew, Inc. | 20 |
| Arthrocare Corp. | 18 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in MBI file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| ArthroCare Corporation | 31 | 2 |
| Parcus Medical, LLC | 23 | 2 |
| Smith & Nephew, Inc. | 23 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MBI
Get an email the morning anything changes in MBI — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.