FDA product code · Orthopedic
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Product code KTT covers Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II device regulated under 21 CFR 888.3030. FDA has cleared 404 devices in this code, 10 of them in the last 12 months. Median review time across the 404 most recent decisions is 75 days. openFDA lists 89 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3030
- Review panel
- Orthopedic
- Clearances
- 404
What is happening in KTT right now?
KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Z-2827-2026, Z-2828-2026, Z-2829-2026, Z-2830-2026, Z-2831-2026). 3 first-time filers in the last 12 months, including Stabiliz Orthopaedics, Inc. and Blue Ocean Global (K260112, K253291, K252555). The code is crowded, scoring 88 of 100 — 146 companies hold a clearance here and 10 arrived in the last 12 months (KTT:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Serious | Z-2827-2026, Z-2828-2026, Z-2829-2026, Z-2830-2026, Z-2831-2026 |
| New entrant | Worth knowing | K260112, K253291, K252555 |
| Crowding | Context | KTT: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 KTT?
FDA has cleared 404 devices under product code KTT since the 510(k) programme began in 1976, 10 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC | |
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | |
| K253291 | Excelsior System | Blue Ocean Global | |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | |
| K253202 | Hoffmann LRF System | Stryker GmbH | |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. |
How long does FDA review take for KTT?
The median FDA review time for KTT is 75 days, measured across the 404 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 KTT?
openFDA lists 89 recall records against product code KTT. A recall record covers one firm's corrective action and may span many device lots.
Z-2827-2026Open, ClassifiedStryker Corporation
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2828-2026Open, ClassifiedStryker Corporation
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2829-2026Open, ClassifiedStryker Corporation
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2830-2026Open, ClassifiedStryker Corporation
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2831-2026Open, ClassifiedStryker Corporation
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Showing the 5 most recently initiated of 89. 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 KTT?
MAUDE holds 1,712 adverse-event reports naming product code KTT, 285 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 KTT unusual?
One month sits above KTT's own expected range: 1 April 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 35 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 62 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 63 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 68 | Insufficient history | No expected range — too little history | |
| 43 | Insufficient history | No expected range — too little history | |
| 51 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 39 | Insufficient history | No expected range — too little history | |
| 33 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 47 | Insufficient history | No expected range — too little history | |
| 64 | Insufficient history | No expected range — too little history | |
| 29 | Insufficient history | No expected range — too little history | |
| 43 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 35 | 14–65 | Within expected (14–65) | |
| 22 | 15–50 | Within expected (15–50) | |
| 50 | 12–54 | Within expected (12–54) | |
| 273 | 18–61 | Above expected (18–61) | |
| 16 | 0–232 | Within expected (0–232) | |
| 15 | 0–215 | Within expected (0–215) | |
| 35 | 0–309 | Within expected (0–309) | |
| 52 | 0–221 | Within expected (0–221) | |
| 43 | 0–230 | Within expected (0–230) | |
| 48 | 0–224 | Within expected (0–224) | |
| 19 | 0–200 | Within expected (0–200) | |
| 66 | 0–213 | Within expected (0–213) | |
| 27 | 0–254 | Within expected (0–254) | |
| 22 | 0–208 | Within expected (0–208) | |
| 21 | 0–223 | Within expected (0–223) |
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 KTT.
Who has entered KTT in the last year?
3 companies filed in KTT for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Stabiliz Orthopaedics, Inc. | K260112 | |
| Blue Ocean Global | K253291 | |
| Medusa Orthopedics, LLC | K252555 |
"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 KTT?
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 KTT?
Across the 404 most recent decisions, these applicants filed most often in KTT.
| Applicant | Recent clearances |
|---|---|
| Ebi, L.P. | 35 |
| Synthes (Usa) | 31 |
| Howmedica Corp. | 20 |
| Howmedica Osteonics Corp. | 19 |
| Smith & Nephew, Inc. | 15 |
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 KTT 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 |
|---|---|---|
| Synthes USA | 32 | 2 |
| Howmedica Corp. | 22 | 2 |
| Smith & Nephew, Inc. | 16 | 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 KTT
Get an email the morning anything changes in KTT — 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.