Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthopedic Systems, Inc. — Predicate Candidate Screening
95 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
114 days90th percentile
95clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | Orthopedic Systems, Inc. | 1996-01-22 | 237 | 0 |
| K920256 | SPINE MOTION ANALYZER WITH EMG | Orthopedic Systems, Inc. | 1992-08-10 | 202 | 0 |
| K910736 | JACKSON MULTIPURPOSE OPERATING TABLE | Orthopedic Systems, Inc. | 1991-05-21 | 89 | 1 |
| K910031 | PARK CITY SHOULDER POSITIONER | Orthopedic Systems, Inc. | 1991-01-24 | 20 | 0 |
| K903938 | C FIT CUP | Orthopedic Systems, Inc. | 1991-01-04 | 130 | 0 |
| K892503 | NUFFIELD TOTAL KNEE | Orthopedic Systems, Inc. | 1990-05-04 | 388 | 0 |
| K896678 | SILICONE PLUG | Orthopedic Systems, Inc. | 1990-01-30 | 64 | 0 |
| K894283 | COMPREHENSIVE SPINE MOTION ANALYZER | Orthopedic Systems, Inc. | 1990-01-19 | 210 | 0 |
| K890331 | FREEMAN TOTAL HIP SYSTEM RIDGED STEM | Orthopedic Systems, Inc. | 1989-10-13 | 263 | 0 |
| K890498 | FREEMAN MODULAR HIP STEM RIDGED VERSION | Orthopedic Systems, Inc. | 1989-10-13 | 254 | 0 |
| K895219 | CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM | Orthopedic Systems, Inc. | 1989-09-12 | 25 | 0 |
| K895218 | CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM | Orthopedic Systems, Inc. | 1989-09-12 | 25 | 0 |
| K895217 | CORTICAL SCREW | Orthopedic Systems, Inc. | 1989-09-12 | 25 | 0 |
| K894249 | UNIVERSAL CEMENTED CUP | Orthopedic Systems, Inc. | 1989-08-03 | 43 | 0 |
| K891539 | CTI II STRAIGHT STEM | Orthopedic Systems, Inc. | 1989-06-08 | 83 | 0 |
| K891903 | COHN TARGETEER | Orthopedic Systems, Inc. | 1989-05-15 | 49 | 0 |
| K890187 | THE C-S DISTRACTION ROD ASSEMBLY | Orthopedic Systems, Inc. | 1989-04-06 | 78 | 0 |
| K890185 | C-S IMPACTOR | Orthopedic Systems, Inc. | 1989-04-06 | 78 | 0 |
| K875130 | BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS | Orthopedic Systems, Inc. | 1989-01-30 | 412 | 0 |
| K884483 | CRUCIOMETER | Orthopedic Systems, Inc. | 1989-01-18 | 85 | 0 |
| K884641 | BOVAC SMOKE COLLECTOR | Orthopedic Systems, Inc. | 1988-12-22 | 45 | 0 |
| K883457 | ASST-3000 SPINAL SURGERY TABLE | Orthopedic Systems, Inc. | 1988-08-26 | 14 | 0 |
| K881511 | FIXATOR PIN (EXTERNAL) | Orthopedic Systems, Inc. | 1988-06-30 | 80 | 0 |
| K881288 | CORIN MODULAR MOORE STEM | Orthopedic Systems, Inc. | 1988-06-29 | 93 | 0 |
| K881289 | CORIN BIPOLAR PROSTHESIS | Orthopedic Systems, Inc. | 1988-06-29 | 93 | 0 |
| K880203 | HERMAN CANNULA SET | Orthopedic Systems, Inc. | 1988-04-14 | 90 | 0 |
| K881060 | OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) | Orthopedic Systems, Inc. | 1988-03-25 | 21 | 0 |
| K880264 | BONE SUTURE FIXATION DEVICE | Orthopedic Systems, Inc. | 1988-03-23 | 61 | 0 |
| K880263 | OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION | Orthopedic Systems, Inc. | 1988-03-15 | 53 | 0 |
| K880253 | BLAKEMORE RETAINER | Orthopedic Systems, Inc. | 1988-03-11 | 51 | 0 |
| K880265 | WEHBE ARM HOLDER | Orthopedic Systems, Inc. | 1988-02-18 | 27 | 0 |
| K874616 | MOORE HIP PROSTHESIS FENESTRATED STEM | Orthopedic Systems, Inc. | 1988-01-29 | 81 | 0 |
| K874599 | MOORE HIP PROSTHESIS SOLID STEM | Orthopedic Systems, Inc. | 1988-01-29 | 81 | 0 |
| K875235 | ISOKINETIC SYSTEM, TESTING AND EVALUATION | Orthopedic Systems, Inc. | 1988-01-19 | 28 | 0 |
| K873660 | ROPER-TUKE ELBOW | Orthopedic Systems, Inc. | 1988-01-06 | 118 | 0 |
| K873626 | FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM | Orthopedic Systems, Inc. | 1987-12-31 | 114 | 0 |
| K873627 | CTI STRAIGHT STEM | Orthopedic Systems, Inc. | 1987-12-30 | 113 | 0 |
| K874617 | THOMPSON HIP PROSTHESIS | Orthopedic Systems, Inc. | 1987-12-10 | 31 | 0 |
| K873632 | HI-NEK TOTAL HIP | Orthopedic Systems, Inc. | 1987-12-07 | 90 | 0 |
| K874130 | TITANIUM BONE SCREWS | Orthopedic Systems, Inc. | 1987-12-07 | 55 | 0 |
| K874300 | AESTHESIOMETER | Orthopedic Systems, Inc. | 1987-11-06 | 17 | 0 |
| K871323 | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | Orthopedic Systems, Inc. | 1987-05-01 | 28 | 0 |
| K871287 | ORTHOPEDIC DRILL GUIDE | Orthopedic Systems, Inc. | 1987-04-15 | 15 | 0 |
| K871225 | HAND SURGERY TABLE EXTENSION | Orthopedic Systems, Inc. | 1987-04-07 | 11 | 0 |
| K870101 | CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION | Orthopedic Systems, Inc. | 1987-02-06 | 28 | 0 |
| K870098 | LITHOTOMY HOLDERS | Orthopedic Systems, Inc. | 1987-02-06 | 28 | 0 |
| K870099 | PIVOTING SURGICAL ARM BOARDS | Orthopedic Systems, Inc. | 1987-02-06 | 28 | 0 |
| K870104 | RADIOLUCENT TABLE EXTENSION | Orthopedic Systems, Inc. | 1987-02-06 | 28 | 0 |
| K870105 | INFANT CAST TABLE | Orthopedic Systems, Inc. | 1987-02-06 | 28 | 0 |
| K870125 | EXTREMITY ELEVATOR | Orthopedic Systems, Inc. | 1987-02-04 | 23 | 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