FDA product code · Orthopedic
PHXShoulder Prosthesis, Reverse Configuration
Product code PHX covers Shoulder Prosthesis, Reverse Configuration, a Class II device regulated under 21 CFR 888.3660. FDA has cleared 205 devices in this code, 20 of them in the last 12 months. Median review time across the 205 most recent decisions is 125 days. openFDA lists 67 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3660
- Review panel
- Orthopedic
- Clearances
- 205
What is happening in PHX right now?
PHX (Shoulder Prosthesis, Reverse Configuration) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2527-2026, Z-2528-2026, Z-2529-2026, Z-2530-2026, Z-2531-2026). 3 first-time filers in the last 12 months, including Stryker Corporation (Tornier, Inc.) and Medacta International, SA (K260102, K261016, K252404). The code is crowded, scoring 76 of 100 — 39 companies hold a clearance here and 20 arrived in the last 12 months (PHX:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2527-2026, Z-2528-2026, Z-2529-2026, Z-2530-2026, Z-2531-2026 |
| New entrant | Worth knowing | K260102, K261016, K252404 |
| Crowding | Context | PHX: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 PHX cover?
PHX is FDA's product code for Shoulder Prosthesis, Reverse Configuration, a Class II device regulated under 21 CFR 888.3660.
Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
Source: openFDA device/classification · record PHX · retrieved
How many devices has FDA cleared in PHX?
FDA has cleared 205 devices under product code PHX since the 510(k) programme began in 1976, 20 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260556 | Veritas Shoulder System | Restor3D | |
| K261683 | Augment Off-Axis Instrument System | Zimmer, Inc. | |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Stryker Corporation (Tornier, Inc.) | |
| K261016 | MSS - Humeral reverse liners extension | Medacta International, SA | |
| K253992 | Veritas Reverse Total Shoulder System | Restor3D | |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | |
| K260583 | Equinoxe® Shoulder System | Exactech, Inc. | |
| K254128 | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | |
| K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | |
| K253624 | INHANCE Reverse Shoulder System | Depuy Ireland UC |
How long does FDA review take for PHX?
The median FDA review time for PHX is 125 days, measured across the 205 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 PHX?
openFDA lists 67 recall records against product code PHX. A recall record covers one firm's corrective action and may span many device lots.
Z-2527-2026Open, ClassifiedZimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Z-2528-2026Open, ClassifiedZimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Z-2529-2026Open, ClassifiedZimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Z-2530-2026Open, ClassifiedZimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Z-2531-2026Open, ClassifiedZimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Showing the 5 most recently initiated of 67. 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 PHX?
MAUDE holds 6,724 adverse-event reports naming product code PHX, 1,992 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 PHX unusual?
2 months sit above PHX's own expected range: 1 April 2025, 1 June 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 77 | Insufficient history | No expected range — too little history | |
| 68 | Insufficient history | No expected range — too little history | |
| 122 | Insufficient history | No expected range — too little history | |
| 98 | Insufficient history | No expected range — too little history | |
| 111 | Insufficient history | No expected range — too little history | |
| 140 | Insufficient history | No expected range — too little history | |
| 118 | Insufficient history | No expected range — too little history | |
| 101 | Insufficient history | No expected range — too little history | |
| 89 | Insufficient history | No expected range — too little history | |
| 130 | Insufficient history | No expected range — too little history | |
| 156 | Insufficient history | No expected range — too little history | |
| 221 | Insufficient history | No expected range — too little history | |
| 262 | Insufficient history | No expected range — too little history | |
| 166 | Insufficient history | No expected range — too little history | |
| 185 | Insufficient history | No expected range — too little history | |
| 149 | Insufficient history | No expected range — too little history | |
| 166 | Insufficient history | No expected range — too little history | |
| 176 | Insufficient history | No expected range — too little history | |
| 213 | Insufficient history | No expected range — too little history | |
| 156 | Insufficient history | No expected range — too little history | |
| 162 | Insufficient history | No expected range — too little history | |
| 129 | 73–240 | Within expected (73–240) | |
| 149 | 58–202 | Within expected (58–202) | |
| 179 | 72–232 | Within expected (72–232) | |
| 253 | 90–243 | Above expected (90–243) | |
| 242 | 115–243 | Within expected (115–243) | |
| 294 | 123–289 | Above expected (123–289) | |
| 314 | 192–535 | Within expected (192–535) | |
| 222 | 140–388 | Within expected (140–388) | |
| 238 | 138–391 | Within expected (138–391) | |
| 273 | 132–379 | Within expected (132–379) | |
| 240 | 122–347 | Within expected (122–347) | |
| 278 | 144–379 | Within expected (144–379) | |
| 285 | 182–432 | Within expected (182–432) | |
| 231 | 169–341 | Within expected (169–341) | |
| 279 | 183–361 | Within expected (183–361) |
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 PHX.
Who has entered PHX in the last year?
3 companies filed in PHX for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Stryker Corporation (Tornier, Inc.) | K260102 | |
| Medacta International, SA | K261016 | |
| Biomet Orthopedics Corp. | K252404 |
"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 PHX?
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 PHX?
Across the 205 most recent decisions, these applicants filed most often in PHX.
| Applicant | Recent clearances |
|---|---|
| Exactech, Inc. | 21 |
| Encore Medical L.P. | 16 |
| Biomet Manufacturing Corp | 13 |
| Medacta International S.A. | 12 |
| Arthrex, Inc. | 11 |
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 PHX 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 |
|---|---|---|
| Tornier, Inc. | 18 | 2 |
| Biomet Manufacturing, 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 PHX
Get an email the morning anything changes in PHX — 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.