FDA product code · Orthopedic
HRXArthroscope
Product code HRX covers Arthroscope, a Class II device regulated under 21 CFR 888.1100. FDA has cleared 681 devices in this code, 10 of them in the last 12 months. Median review time across the 681 most recent decisions is 89 days. openFDA lists 126 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.1100
- Review panel
- Orthopedic
- Clearances
- 681
What is happening in HRX right now?
HRX (Arthroscope) has three findings, most consequential first. 7 first-time filers in the last 12 months, including Spinal Simplicity, LLC and Allevion Medical, LLC (K253523, K252546, K253217, K252666, K252458). Clearances are running 20% slower — a median 107 days over the last 12 months against 89 days all-time (elapsed calendar days, not FDA review days) (HRX:review_time:12m). The code is crowded, scoring 97 of 100 — 269 companies hold a clearance here and 10 arrived in the last 12 months (HRX:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253523, K252546, K253217, K252666, K252458 |
| Review time | Context | HRX:review_time:12m |
| Crowding | Context | HRX: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.
What does product code HRX cover?
HRX is FDA's product code for Arthroscope, a Class II device regulated under 21 CFR 888.1100.
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Source: openFDA device/classification · record HRX · retrieved
How many devices has FDA cleared in HRX?
FDA has cleared 681 devices under product code HRX 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 |
|---|---|---|---|
| K252790 | Digital ClarusScope System and Digital NeuroPEN System | Clarus Medical, LLC | |
| K253523 | Freedom DS Decompression System | Spinal Simplicity | |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | |
| K250795 | PUREVUE FMS | W.O.M. World of Medicine GmbH | |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations |
How long does FDA review take for HRX?
The median FDA review time for HRX is 89 days, measured across the 681 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 HRX?
openFDA lists 126 recall records against product code HRX. A recall record covers one firm's corrective action and may span many device lots.
Z-1453-2025Open, ClassifiedMEDLINE INDUSTRIES, LP - Northfield
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Z-0526-2025Open, ClassifiedKarl Storz Endoscopy
Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
Z-2243-2024Open, ClassifiedWOM World of Medicine AG
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
Z-3053-2024Open, ClassifiedMEDLINE INDUSTRIES, LP - Northfield
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-0144-2022TerminatedADRIA SRL
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
Showing the 5 most recently initiated of 126. 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 HRX?
MAUDE holds 6,121 adverse-event reports naming product code HRX, 1,266 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 HRX unusual?
Every month with enough history behind it falls inside HRX's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 119 | Insufficient history | No expected range — too little history | |
| 85 | Insufficient history | No expected range — too little history | |
| 152 | Insufficient history | No expected range — too little history | |
| 137 | Insufficient history | No expected range — too little history | |
| 122 | Insufficient history | No expected range — too little history | |
| 144 | Insufficient history | No expected range — too little history | |
| 106 | Insufficient history | No expected range — too little history | |
| 131 | Insufficient history | No expected range — too little history | |
| 113 | Insufficient history | No expected range — too little history | |
| 180 | Insufficient history | No expected range — too little history | |
| 171 | Insufficient history | No expected range — too little history | |
| 188 | Insufficient history | No expected range — too little history | |
| 188 | Insufficient history | No expected range — too little history | |
| 304 | Insufficient history | No expected range — too little history | |
| 300 | Insufficient history | No expected range — too little history | |
| 158 | Insufficient history | No expected range — too little history | |
| 121 | Insufficient history | No expected range — too little history | |
| 177 | Insufficient history | No expected range — too little history | |
| 198 | Insufficient history | No expected range — too little history | |
| 160 | Insufficient history | No expected range — too little history | |
| 282 | Insufficient history | No expected range — too little history | |
| 222 | 69–315 | Within expected (69–315) | |
| 147 | 67–283 | Within expected (67–283) | |
| 126 | 66–307 | Within expected (66–307) | |
| 196 | 44–305 | Within expected (44–305) | |
| 163 | 48–293 | Within expected (48–293) | |
| 163 | 62–288 | Within expected (62–288) | |
| 182 | 144–387 | Within expected (144–387) | |
| 142 | 85–278 | Within expected (85–278) | |
| 151 | 82–276 | Within expected (82–276) | |
| 187 | 68–271 | Within expected (68–271) | |
| 145 | 66–249 | Within expected (66–249) | |
| 211 | 68–276 | Within expected (68–276) | |
| 136 | 120–303 | Within expected (120–303) | |
| 170 | 89–229 | Within expected (89–229) | |
| 170 | 103–251 | Within expected (103–251) |
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 HRX.
Who has entered HRX in the last year?
7 companies filed in HRX for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Spinal Simplicity, LLC | K253523 | |
| Allevion Medical, LLC | K252546 | |
| Medimaging Integrated Solution, Inc (Miis) | K253217 | |
| Joint Preservation Innovations, LLC | K252666 | |
| Shanghai Lange Medtech Co., Ltd. | K252458 | |
| SONEX HEALTH LLC | K252594 | |
| Lesspine Innovations | K243774 |
"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 HRX?
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 HRX?
Across the 681 most recent decisions, these applicants filed most often in HRX.
| Applicant | Recent clearances |
|---|---|
| KARL STORZ Endoscopy-America, Inc. | 28 |
| Arthrex, Inc. | 27 |
| Acufex Microsurgical, Inc. | 26 |
| Linvatec Corp. | 19 |
| Smith & Nephew, Inc. | 18 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in HRX files 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 |
|---|---|---|
| Smith & Nephew, Inc. | 19 | 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 HRX
Get an email the morning anything changes in HRX — 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.