Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wrightmedicaltechnologyinc — Predicate Candidate Screening
302 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
245 days90th percentile
302clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2023-01-27 | 129 | 0 |
| K213342 | PRO-DENSE LoVisc Bone Graft Substitute | Wrightmedicaltechnologyinc | 2022-01-05 | 90 | 0 |
| K212996 | Sterile PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2021-11-16 | 57 | 0 |
| K202815 | PROPHECY Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2021-03-10 | 167 | 0 |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System | Wrightmedicaltechnologyinc | 2021-01-08 | 242 | 0 |
| K200507 | PRO-DENSE LoVisc Bone Graft Substitute | Wrightmedicaltechnologyinc | 2020-10-21 | 233 | 0 |
| K193067 | The INBONE™ Total Ankle System, the INFINITY™ Total Ankle Sy | Wrightmedicaltechnologyinc | 2020-06-08 | 217 | 0 |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Wrightmedicaltechnologyinc | 2019-08-22 | 90 | 0 |
| K190970 | PROSTEP™ TBI™ (Tailors Bunion Implant) System | Wrightmedicaltechnologyinc | 2019-08-13 | 123 | 0 |
| K183620 | PROSTEP TBC Implant System | Wrightmedicaltechnologyinc | 2019-06-06 | 162 | 0 |
| K190482 | IGNITE Bone Void Filler | Wrightmedicaltechnologyinc | 2019-05-28 | 90 | 0 |
| K190670 | ORTHOLOC™ 2 Lapidus with Rotation System | Wrightmedicaltechnologyinc | 2019-05-14 | 60 | 0 |
| K190283 | PROSTIM Injectable Inductive Graft | Wrightmedicaltechnologyinc | 2019-03-14 | 31 | 0 |
| K183026 | Wright Jones Fracture System | Wrightmedicaltechnologyinc | 2019-03-13 | 132 | 0 |
| K181377 | PROSTEP MICA Screw System | Wrightmedicaltechnologyinc | 2019-01-11 | 232 | 0 |
| K182823 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018-11-02 | 29 | 0 |
| K181255 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018-09-12 | 124 | 0 |
| K181557 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018-08-09 | 57 | 0 |
| K180730 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2018-07-11 | 113 | 0 |
| K180024 | SALVATION Midfoot Nail | Wrightmedicaltechnologyinc | 2018-07-11 | 189 | 0 |
| K180832 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | 2018-06-06 | 68 | 0 |
| K172633 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018-04-26 | 237 | 0 |
| K171852 | DARCO Locking Bone Plate System | Wrightmedicaltechnologyinc | 2017-09-21 | 92 | 0 |
| K171067 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2017-09-11 | 154 | 0 |
| K170642 | GRAVITY™ Soft Tissue Repair System | Wrightmedicaltechnologyinc | 2017-08-22 | 173 | 0 |
| K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017-08-16 | 138 | 0 |
| K170249 | GRAVITY™ Syndesmosis LP | Wrightmedicaltechnologyinc | 2017-06-30 | 154 | 0 |
| K170889 | HV Screw System | Wrightmedicaltechnologyinc | 2017-04-26 | 33 | 0 |
| K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | Wrightmedicaltechnologyinc | 2017-04-24 | 122 | 0 |
| K162353 | MICATM Screw System | Wrightmedicaltechnologyinc | 2017-04-13 | 233 | 0 |
| K163039 | ORTHOLOC® 3Di Small Bones Plating | Wrightmedicaltechnologyinc | 2017-03-13 | 133 | 0 |
| K170265 | GRAVITYTM PEEK-OPTIMA Suture Anchor | Wrightmedicaltechnologyinc | 2017-02-23 | 27 | 0 |
| K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017-02-22 | 141 | 0 |
| K163044 | ORTHOLOC® 3Di Ankle Fracture Plating System | Wrightmedicaltechnologyinc | 2017-01-26 | 87 | 0 |
| K152062 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2016-05-17 | 298 | 0 |
| K153008 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2016-05-06 | 205 | 0 |
| K153635 | SALVATION(R) External Fixation System | Wrightmedicaltechnologyinc | 2016-01-13 | 26 | 0 |
| K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015-12-11 | 64 | 0 |
| K150640 | RX-FIX Mini Rail External Fixator | Wrightmedicaltechnologyinc | 2015-12-01 | 265 | 0 |
| K151442 | TOTAL COMPRESSION PLATING (TCP) SYSTEM | Wrightmedicaltechnologyinc | 2015-09-04 | 98 | 0 |
| K151838 | PRO-TOE Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2015-09-04 | 60 | 0 |
| K152045 | SALVATION® External Fixation System | Wrightmedicaltechnologyinc | 2015-08-21 | 29 | 0 |
| K142724 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2015-05-20 | 239 | 0 |
| K150213 | Subtalar Spacer System (STS) | Wrightmedicaltechnologyinc | 2015-05-08 | 98 | 0 |
| K150520 | DARCO Locking Bone Plate System | Wrightmedicaltechnologyinc | 2015-04-29 | 58 | 0 |
| K150252 | PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2015-04-29 | 85 | 0 |
| K142117 | INVISION TOTAL ANKLE REVISION SYSTEM | Wrightmedicaltechnologyinc | 2015-03-25 | 233 | 0 |
| K141740 | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM | Wrightmedicaltechnologyinc | 2015-03-05 | 251 | 0 |
| K150004 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | 2015-03-04 | 61 | 0 |
| K150073 | MICRONAIL Distal Radius System | Wrightmedicaltechnologyinc | 2015-02-10 | 27 | 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