FDA product code · Orthopedic
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Product code LPH covers Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II device regulated under 21 CFR 888.3358. FDA has cleared 562 devices in this code, 9 of them in the last 12 months. Median review time across the 562 most recent decisions is 90 days. openFDA lists 297 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3358
- Review panel
- Orthopedic
- Clearances
- 562
What is happening in LPH right now?
LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1234-2026, Z-0418-2026, Z-0419-2026, Z-0148-2026, Z-0149-2026). 3 first-time filers in the last 12 months, including Nextstep Arthopedix, LLC and restor3d Inc (K243192, K252067, K252846). The code is crowded, scoring 84 of 100 — 107 companies hold a clearance here and 9 arrived in the last 12 months (LPH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1234-2026, Z-0418-2026, Z-0419-2026, Z-0148-2026, Z-0149-2026 |
| New entrant | Worth knowing | K243192, K252067, K252846 |
| Crowding | Context | LPH: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 LPH?
FDA has cleared 562 devices under product code LPH since the 510(k) programme began in 1976, 9 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | |
| K251270 | Taperloc® Complete Hip Stem | Biomet, Inc. | |
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | |
| K251043 | Mpact 3D Metal Implants Extension DMLS Technology | Medacta International S.A. | |
| K252067 | Velora Acetabular System | Restor3D, Inc. | |
| K252846 | TaperSet Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) |
How long does FDA review take for LPH?
The median FDA review time for LPH is 90 days, measured across the 562 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 LPH?
openFDA lists 297 recall records against product code LPH. A recall record covers one firm's corrective action and may span many device lots.
Z-1234-2026Open, ClassifiedEncore Medical, Lp
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Z-0418-2026Open, ClassifiedZimmer, Inc.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Z-0419-2026Open, ClassifiedZimmer, Inc.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Z-0148-2026Open, ClassifiedBiopro, Inc.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Z-0149-2026Open, ClassifiedBiopro, Inc.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Showing the 5 most recently initiated of 297. 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 LPH?
MAUDE holds 16,921 adverse-event reports naming product code LPH, 3,872 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 LPH unusual?
2 months sit above LPH's own expected range: 1 April 2025, 1 June 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 415 | Insufficient history | No expected range — too little history | |
| 394 | Insufficient history | No expected range — too little history | |
| 509 | Insufficient history | No expected range — too little history | |
| 385 | Insufficient history | No expected range — too little history | |
| 444 | Insufficient history | No expected range — too little history | |
| 473 | Insufficient history | No expected range — too little history | |
| 420 | Insufficient history | No expected range — too little history | |
| 444 | Insufficient history | No expected range — too little history | |
| 364 | Insufficient history | No expected range — too little history | |
| 406 | Insufficient history | No expected range — too little history | |
| 449 | Insufficient history | No expected range — too little history | |
| 498 | Insufficient history | No expected range — too little history | |
| 476 | Insufficient history | No expected range — too little history | |
| 546 | Insufficient history | No expected range — too little history | |
| 518 | Insufficient history | No expected range — too little history | |
| 484 | Insufficient history | No expected range — too little history | |
| 362 | Insufficient history | No expected range — too little history | |
| 455 | Insufficient history | No expected range — too little history | |
| 566 | Insufficient history | No expected range — too little history | |
| 386 | Insufficient history | No expected range — too little history | |
| 482 | Insufficient history | No expected range — too little history | |
| 404 | 289–555 | Within expected (289–555) | |
| 327 | 249–478 | Within expected (249–478) | |
| 342 | 261–529 | Within expected (261–529) | |
| 537 | 251–533 | Above expected (251–533) | |
| 462 | 268–550 | Within expected (268–550) | |
| 586 | 298–583 | Above expected (298–583) | |
| 639 | 508–1,009 | Within expected (508–1,009) | |
| 528 | 355–734 | Within expected (355–734) | |
| 574 | 389–750 | Within expected (389–750) | |
| 546 | 389–748 | Within expected (389–748) | |
| 546 | 345–663 | Within expected (345–663) | |
| 572 | 407–741 | Within expected (407–741) | |
| 472 | 469–852 | Within expected (469–852) | |
| 376 | 331–690 | Within expected (331–690) | |
| 375 | 300–730 | Within expected (300–730) |
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 LPH.
Who has entered LPH in the last year?
3 companies filed in LPH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Nextstep Arthopedix, LLC | K243192 | |
| restor3d Inc. | K252067 | |
| Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | K252846 |
"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 LPH?
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 LPH?
Across the 562 most recent decisions, these applicants filed most often in LPH.
| Applicant | Recent clearances |
|---|---|
| Zimmer, Inc. | 45 |
| Biomet, Inc. | 44 |
| DePuy Orthopaedics, Inc. | 32 |
| Smith & Nephew, Inc. | 32 |
| Depuy, Inc. | 24 |
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 LPH 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 |
|---|---|---|
| Zimmer, Inc. | 46 | 2 |
| DePuy Orthopaedics, Inc. | 33 | 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 LPH
Get an email the morning anything changes in LPH — 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.