FDA product code · Orthopedic
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Product code LZO covers Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a Class II device regulated under 21 CFR 888.3353. FDA has cleared 532 devices in this code, 7 of them in the last 12 months. Median review time across the 532 most recent decisions is 94 days. openFDA lists 177 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3353
- Review panel
- Orthopedic
- Clearances
- 532
What is happening in LZO right now?
LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented) has two findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0151-2026). The code is crowded, scoring 67 of 100 — 97 companies hold a clearance here and 7 arrived in the last 12 months (LZO:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0151-2026 |
| Crowding | Context | LZO: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 LZO?
FDA has cleared 532 devices under product code LZO since the 510(k) programme began in 1976, 7 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | |
| K260831 | Z1 Hip System | Zimmer, Inc. | |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip System | Zimmer, Inc. | |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | |
| K252401 | implaFit® short stems | Implantcast GmbH | |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | |
| K250450 | Coated hip implants | Medacta International S.A. | |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | |
| K251906 | Z1 Hip System | Zimmer, Inc. | |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC |
How long does FDA review take for LZO?
The median FDA review time for LZO is 94 days, measured across the 532 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 LZO?
openFDA lists 177 recall records against product code LZO. A recall record covers one firm's corrective action and may span many device lots.
Z-0151-2026Open, 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-1645-2025Open, ClassifiedZimmer, Inc.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Z-1646-2025Open, ClassifiedZimmer, Inc.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Z-1647-2025Open, ClassifiedZimmer, Inc.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Z-1648-2025Open, ClassifiedZimmer, Inc.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Showing the 5 most recently initiated of 177. 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 LZO?
MAUDE holds 7,961 adverse-event reports naming product code LZO, 1,888 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 LZO unusual?
One month sits above LZO's own expected range: 1 April 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 190 | Insufficient history | No expected range — too little history | |
| 147 | Insufficient history | No expected range — too little history | |
| 148 | Insufficient history | No expected range — too little history | |
| 158 | Insufficient history | No expected range — too little history | |
| 163 | Insufficient history | No expected range — too little history | |
| 179 | Insufficient history | No expected range — too little history | |
| 183 | Insufficient history | No expected range — too little history | |
| 173 | Insufficient history | No expected range — too little history | |
| 129 | Insufficient history | No expected range — too little history | |
| 211 | Insufficient history | No expected range — too little history | |
| 171 | Insufficient history | No expected range — too little history | |
| 208 | Insufficient history | No expected range — too little history | |
| 212 | Insufficient history | No expected range — too little history | |
| 291 | Insufficient history | No expected range — too little history | |
| 245 | Insufficient history | No expected range — too little history | |
| 231 | Insufficient history | No expected range — too little history | |
| 217 | Insufficient history | No expected range — too little history | |
| 176 | Insufficient history | No expected range — too little history | |
| 197 | Insufficient history | No expected range — too little history | |
| 186 | Insufficient history | No expected range — too little history | |
| 241 | Insufficient history | No expected range — too little history | |
| 189 | 125–264 | Within expected (125–264) | |
| 137 | 106–228 | Within expected (106–228) | |
| 232 | 107–248 | Within expected (107–248) | |
| 387 | 125–276 | Above expected (125–276) | |
| 269 | 120–363 | Within expected (120–363) | |
| 304 | 131–386 | Within expected (131–386) | |
| 364 | 212–642 | Within expected (212–642) | |
| 255 | 146–470 | Within expected (146–470) | |
| 261 | 139–475 | Within expected (139–475) | |
| 295 | 131–452 | Within expected (131–452) | |
| 216 | 126–402 | Within expected (126–402) | |
| 285 | 129–425 | Within expected (129–425) | |
| 200 | 152–491 | Within expected (152–491) | |
| 173 | 86–396 | Within expected (86–396) | |
| 261 | 69–417 | Within expected (69–417) |
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 LZO.
What are the predicate devices in LZO?
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 LZO?
Across the 532 most recent decisions, these applicants filed most often in LZO.
| Applicant | Recent clearances |
|---|---|
| Medacta International S.A. | 27 |
| Smith & Nephew, Inc. | 24 |
| Howmedica Osteonics Corp. | 23 |
| Zimmer, Inc. | 23 |
| Biomet, Inc. | 21 |
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 LZO 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. | 34 | 2 |
| Howmedica Osteonics Corp. | 27 | 3 |
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 LZO
Get an email the morning anything changes in LZO — 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.