FDA product code LXI: Guide, Drill, Ligament
LXI is the FDA product code for guide, drill, ligament. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Orthopedic panel. FDA has cleared 8 510(k) submissions under LXI, from 8 different applicants. The average 510(k) review took 126 days (median 89).
Classification
| Field | Value |
|---|---|
| Device name | Guide, Drill, Ligament |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LXI clearance
Top LXI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synvasive Technology, Inc. | 1 | 1994-04-07 |
| Physio Systems, Inc. | 1 | 1991-05-21 |
| Baxter Healthcare Corp | 1 | 1989-09-28 |
| Silent Call Corp. | 1 | 1989-05-19 |
| Instrument Makar, Inc. | 1 | 1988-09-06 |
3 more applicants have LXI clearances. See the full list in Caduvo.
Most recent LXI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930573 | Synvasive Technology, Inc. | SYNVASIVE CERAMIC SUTTING BLOCK | 1994-04-07 | 427 |
| K910712 | Physio Systems, Inc. | VILLAN (VIDEO LIFT LINK ANALYSIS) | 1991-05-21 | 90 |
| K892655 | Baxter Healthcare Corp | ACL DRILL GUIDE SYSTEM | 1989-09-28 | 168 |
| K890445 | Silent Call Corp. | PERSONAL ALERT ASSIST DEVICE | 1989-05-19 | 112 |
| K882407 | Instrument Makar, Inc. | BOW & ARROW DRILL GUIDE | 1988-09-06 | 88 |
Recalls for LXI devices
openFDA lists no recalls for product code LXI.
Frequently asked questions
What is FDA product code LXI?
LXI is the FDA product code for guide, drill, ligament. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Orthopedic panel.
What device class is LXI?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LXI?
Across 8 cleared submissions the average was 126 days from receipt to decision (median 89).
Which companies have the most LXI clearances?
Synvasive Technology, Inc. (1); Physio Systems, Inc. (1); Baxter Healthcare Corp (1); Silent Call Corp. (1); Instrument Makar, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LXI
- Run a recall and safety report across every LXI manufacturer
- Watch product code LXI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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