Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JDX — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
226 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201274 | Ultrasonic Osteotomy Surgical System | Smtp Technology Co., Ltd. | 2021-02-19 | 283 | 0 |
| K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | 2018-04-24 | 253 | 0 |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | 2017-05-19 | 148 | 0 |
| K153743 | PIEZOSURGERY PLUS | Mectron S.P.A. | 2016-05-25 | 149 | 0 |
| K132848 | PIEZOSURGERY FLEX | Mectron S.P.A. | 2013-11-29 | 79 | 0 |
| K100410 | PIEZOELECTRIC SYSTEM | Satelec | 2010-04-28 | 71 | 0 |
| K093805 | OSCAR 3 | Orthosonics, Ltd. | 2010-02-19 | 70 | 0 |
| K083284 | PIEZOSURGERY MEDICAL | Piezosurgery S.R.L. | 2009-04-08 | 152 | 0 |
| K083830 | OSCAR BONE RESECTOR | Orthosonics, Ltd. | 2009-03-20 | 87 | 0 |
| K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USC | Sra Developments, Ltd. | 2007-12-19 | 61 | 0 |
| K051053 | OSCAR, MODEL OE3000DB | Orthosonics, Ltd. | 2005-07-21 | 87 | 0 |
| K031280 | ULTRA-DRIVE 3 | Biomet, Inc. | 2003-09-22 | 153 | 1 |
| K022729 | VENTED CEMENT RESTRICTOR | Amedica Corp. | 2002-11-14 | 90 | 0 |
| K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REM | Electro Medical Systems SA | 2000-10-04 | 51 | 0 |
| K961725 | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION | C.L. Mcintosh & Assoc., Inc. | 1996-08-01 | 90 | 0 |
| K930109 | KOMET MEDICAL SURGICAL POWER ACCESORIES | Brassler USA | 1993-08-25 | 226 | 0 |
| K912931 | ITM SONIC SURGERY SYSTEM | Buckman Co., Inc. | 1991-10-03 | 90 | 0 |
| K911548 | ACRYL-X SYSTEM TM | Sonokinetics, Inc. | 1991-06-28 | 81 | 0 |
| K905451 | SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE | Advanced Osseous Technologies | 1991-03-05 | 90 | 0 |
| K900003 | SYSTEM TEN MODEL 100 SURGICAL SYSTEM | Advanced Osseous Technologies | 1990-03-16 | 73 | 0 |
| K891408 | MODIFIED PROFILE HIP ACETABULAR PROSTHESIS | Depuy, Inc. | 1989-06-12 | 90 | 0 |
| K862504 | ACE MOS SAW AND THE ACE MOS SPINE SAW | Buckman Co., Inc. | 1986-08-07 | 37 | 0 |
| K800501 | PFIZER/AS&E 0450 LOCALIZER | Pfizer Medical Systems, Inc. | 1980-04-10 | 37 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda