FDA product code · Orthopedic
MNIOrthosis, Spinal Pedicle Fixation
Product code MNI covers Orthosis, Spinal Pedicle Fixation, a Class II device regulated under 21 CFR 888.3070. FDA has cleared 303 devices in this code. Median review time across the 303 most recent decisions is 73 days. openFDA lists 213 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3070
- Review panel
- Orthopedic
- Clearances
- 303
What is happening in MNI right now?
MNI (Orthosis, Spinal Pedicle Fixation) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1773-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1773-2026 |
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 MNI?
FDA has cleared 303 devices under product code MNI since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co. , Ltd. | |
| K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | |
| K151458 | Double Medical Universal Spine System | Double Medical Technology, Inc. | |
| K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | Spinevision S.A. | |
| K160320 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | |
| K160003 | Sniper (R) Spine System | Spine Wave, Inc. | |
| K152324 | YAHUA Spinal System | Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. | |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | |
| K150684 | WASTON General Spinal System | Changzhou Waston Medical Appliance Co., Ltd. |
How long does FDA review take for MNI?
The median FDA review time for MNI is 73 days, measured across the 303 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 MNI?
openFDA lists 213 recall records against product code MNI. A recall record covers one firm's corrective action and may span many device lots.
Z-1773-2026Open, ClassifiedXtant Medical Holdings, Inc.
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Z-2458-2023Open, ClassifiedMedicrea International
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Z-1030-2019TerminatedCTL Medical Corporation
the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.
Z-2873-2017TerminatedValorem Surgical LLC
Devices are not consistent with Quality System Requirements.
Z-2874-2017TerminatedValorem Surgical LLC
Devices are not consistent with Quality System Requirements.
Showing the 5 most recently initiated of 213. 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 MNI?
MAUDE holds 302 adverse-event reports naming product code MNI, 36 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 MNI unusual?
One month sits above MNI's own expected range: 1 July 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 10 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 54 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | 0–33 | Within expected (0–33) | |
| 2 | 0–10 | Within expected (0–10) | |
| 6 | 0–11 | Within expected (0–11) | |
| 3 | 0–12 | Within expected (0–12) | |
| 4 | 0–11 | Within expected (0–11) | |
| 4 | 0–12 | Within expected (0–12) | |
| 25 | 0–15 | Above expected (0–15) | |
| 6 | 0–18 | Within expected (0–18) | |
| 2 | 0–18 | Within expected (0–18) | |
| 2 | 0–16 | Within expected (0–16) | |
| 8 | 0–14 | Within expected (0–14) | |
| 13 | 0–16 | Within expected (0–16) | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history |
23 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 MNI.
What are the predicate devices in MNI?
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 MNI?
Across the 303 most recent decisions, these applicants filed most often in MNI.
| Applicant | Recent clearances |
|---|---|
| K2m, Inc. | 14 |
| Medtronic Sofamor Danek, Inc. | 12 |
| Medtronic Sofamor Danek | 11 |
| Spine Wave, Inc. | 11 |
| Spinal USA | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in MNI 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 |
|---|---|---|
| Medtronic Sofamor Danek, Inc. | 23 | 2 |
| K2M, Inc. | 15 | 2 |
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 MNI
Get an email the morning anything changes in MNI — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Orthopedic
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.