Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JDO — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
219 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230764 | OsteoCentric Integrated Hip Fastener System | OsteoCentric Technologies | 2023-04-18 | 29 | 0 |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-L | Smith & Nephew, Inc. | 2022-09-29 | 367 | 0 |
| K210247 | OsteoCentric Integrated Hip Fastener System | Osteocentric Technologies D.B.A. Osteocentric Trauma | 2021-04-30 | 91 | 0 |
| K193029 | CONQUEST FN | Smith & Nephew, Inc. | 2020-02-28 | 121 | 0 |
| K173826 | THP Hip Fracture Plating System | Biomet, Inc. | 2018-02-07 | 51 | 0 |
| K172785 | CONQUEST FN | Smith & Nephew | 2017-12-22 | 98 | 0 |
| K152686 | CONQUEST FN | Smith & Nephew | 2016-03-17 | 181 | 0 |
| K140018 | TSP HIP FRACTURE PLATING SYSTEM | Biomet, Inc. | 2014-04-04 | 91 | 2 |
| K080685 | HIPLOC COMPRESSION HIP SCREW | Biomet Manufacturing, Inc. | 2008-08-15 | 157 | 0 |
| K080434 | INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW | Smith & Nephew, Inc. | 2008-04-10 | 51 | 0 |
| K983814 | GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM | Efratgo, Ltd. HI Tech Bio-Surgical | 1999-01-14 | 78 | 0 |
| K981757 | SYNTHES (USA) DHS HELIX SYSTEM | Synthes (Usa) | 1998-07-17 | 59 | 0 |
| K964259 | SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION | Synthes (Usa) | 1997-01-09 | 76 | 0 |
| K962644 | VIGOR COMPRESSION HIP SCREW SYSTEM | Deutschland Surgical, Inc. | 1996-09-06 | 60 | 0 |
| K953607 | TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) | Synthes (Usa) | 1996-03-08 | 219 | 0 |
| K951904 | SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] | Synthes (Usa) | 1995-07-17 | 84 | 0 |
| K934161 | PROFORM HIP SYSTEM | Stelkast Company | 1994-03-10 | 195 | 0 |
| K934162 | PROFORM HA HIP SYSTEM | Stelkast Company | 1994-03-09 | 194 | 0 |
| K923613 | SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT | Synthes (Usa) | 1993-06-22 | 336 | 0 |
| K831076 | COMPRESSION SYSTEM | Kirschner Medical Corp. | 1983-04-28 | 24 | 0 |
| K810258 | PROXIMAL FERMORAL HIP REPLACEMENT | Biomet, Inc. | 1981-03-05 | 34 | 0 |
| K781389 | BIOMET CONCENTRIC HEX SCREW | Biomet, Inc. | 1978-08-21 | 11 | 0 |
| K780187 | NAIL, MASSIE II | Howmedica Corp. | 1978-03-15 | 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