Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith & Nephew Richards, Inc. — Predicate Candidate Screening
87 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
392 days90th percentile
87clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K965224 | EMPOWER ANTERIOR DIRECT SCREWS | Smith & Nephew Richards, Inc. | 1997-05-08 | 129 | 0 |
| K963509 | GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON | Smith & Nephew Richards, Inc. | 1997-01-27 | 146 | 0 |
| K960444 | FINN ROD TO ROD CONNECTOR | Smith & Nephew Richards, Inc. | 1997-01-24 | 358 | 0 |
| K964163 | TRIMAX NAIL SYSTEM | Smith & Nephew Richards, Inc. | 1996-12-27 | 71 | 0 |
| K962557 | GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMO | Smith & Nephew Richards, Inc. | 1996-12-05 | 157 | 1 |
| K963486 | REVISION HIP SYSTEM | Smith & Nephew Richards, Inc. | 1996-11-27 | 85 | 0 |
| K962541 | REFLECTION ACETABULAR REINFORCEMENT RINGS | Smith & Nephew Richards, Inc. | 1996-09-17 | 81 | 0 |
| K962808 | ILIZAROV EXTERNAL FIXATION SYSTEM | Smith & Nephew Richards, Inc. | 1996-08-19 | 32 | 0 |
| K962137 | GENESIS II CONSTRAINED SYSTEM | Smith & Nephew Richards, Inc. | 1996-08-02 | 60 | 0 |
| K955767 | COFIED MODULAR SHOULDER SYSTEM | Smith & Nephew Richards, Inc. | 1996-04-08 | 109 | 0 |
| K960094 | REFLECTION DUAL DIMENSION SHELL | Smith & Nephew Richards, Inc. | 1996-03-27 | 76 | 1 |
| K954696 | ROGOZINSKI THORACOLUMBAR SPINAL ROD | Smith & Nephew Richards, Inc. | 1996-03-11 | 151 | 0 |
| K953274 | GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM | Smith & Nephew Richards, Inc. | 1996-02-05 | 206 | 0 |
| K954909 | PROFIX POSTERIOR-STABILIZED KNEE SYSTEM | Smith & Nephew Richards, Inc. | 1996-01-31 | 98 | 0 |
| K955552 | EXPRESSAIRE TORUNIQUET SYSTEM | Smith & Nephew Richards, Inc. | 1996-01-05 | 31 | 0 |
| K954491 | HYDROCELL NASAL AND SINUS PACKS | Smith & Nephew Richards, Inc. | 1995-11-15 | 49 | 0 |
| K954712 | INTRAMEDULLARY HIP SCREW (MODIFICATION) | Smith & Nephew Richards, Inc. | 1995-10-31 | 76 | 0 |
| K953397 | HEX-FIX FIELD FIXATOR | Smith & Nephew Richards, Inc. | 1995-10-31 | 103 | 0 |
| K952697 | TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM | Smith & Nephew Richards, Inc. | 1995-09-12 | 91 | 0 |
| K952271 | GENESIS CONSTRAINED SYSTEM (GCS) | Smith & Nephew Richards, Inc. | 1995-09-08 | 116 | 0 |
| K950865 | ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECT | Smith & Nephew Richards, Inc. | 1995-09-01 | 186 | 0 |
| K951987 | GENESIS II TOTAL KNEE SYSTEM | Smith & Nephew Richards, Inc. | 1995-08-22 | 117 | 4 |
| K950093 | AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES | Smith & Nephew Richards, Inc. | 1995-08-15 | 217 | 0 |
| K946088 | GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM | Smith & Nephew Richards, Inc. | 1995-08-08 | 238 | 0 |
| K953096 | ESSENTIAL SHAVER SYSTEM | Smith & Nephew Richards, Inc. | 1995-07-28 | 25 | 0 |
| K951389 | REUNION BONE SCREW SYSTEM | Smith & Nephew Richards, Inc. | 1995-07-24 | 119 | 0 |
| K946236 | PROFIX CONFORMING PLUS TIBIAL INSERT | Smith & Nephew Richards, Inc. | 1995-07-06 | 196 | 0 |
| K952549 | RICHARDS TORP | Smith & Nephew Richards, Inc. | 1995-07-03 | 31 | 0 |
| K952481 | RICHARDS PORP | Smith & Nephew Richards, Inc. | 1995-06-16 | 17 | 0 |
| K934590 | IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANT | Smith & Nephew Richards, Inc. | 1995-06-14 | 628 | 0 |
| K930298 | ROGOZINSKI SPINAL ROD SYSTEM SCREW | Smith & Nephew Richards, Inc. | 1995-06-14 | 874 | 0 |
| K952207 | NASAL SEPTAL SPLINT | Smith & Nephew Richards, Inc. | 1995-06-07 | 28 | 0 |
| K950394 | TIBIA-TALUS-CALCANEUS NAIL | Smith & Nephew Richards, Inc. | 1995-05-19 | 107 | 0 |
| K951803 | ROSSITER SINUS STENT | Smith & Nephew Richards, Inc. | 1995-05-11 | 22 | 0 |
| K951066 | RAINS FRONTAL SINUS STENT | Smith & Nephew Richards, Inc. | 1995-04-04 | 27 | 0 |
| K935235 | ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY | Smith & Nephew Richards, Inc. | 1995-03-23 | 507 | 0 |
| K950927 | HAPEX MALLEABLE TORP | Smith & Nephew Richards, Inc. | 1995-03-21 | 20 | 0 |
| K950886 | HAPEX PORP | Smith & Nephew Richards, Inc. | 1995-03-15 | 15 | 0 |
| K950885 | HAPEX MALLEABLE PORP | Smith & Nephew Richards, Inc. | 1995-03-15 | 15 | 0 |
| K950984 | HAPES MALLEABLE INCUS STAPES | Smith & Nephew Richards, Inc. | 1995-03-15 | 12 | 0 |
| K950887 | HAPEX INCUS | Smith & Nephew Richards, Inc. | 1995-03-15 | 15 | 0 |
| K933958 | RICHARDS TOTAL KNEE SYSTEM | Smith & Nephew Richards, Inc. | 1995-01-09 | 514 | 0 |
| K943523 | ANTERIOR CERVIAL PLATING SYSTEM | Smith & Nephew Richards, Inc. | 1994-12-19 | 151 | 0 |
| K935921 | ZIRCONIA CERAMIC FEMORAL HEAD | Smith & Nephew Richards, Inc. | 1994-11-28 | 376 | 0 |
| K942760 | PNEUMATIC WIRE TENSIONER | Smith & Nephew Richards, Inc. | 1994-09-06 | 85 | 0 |
| K931131 | THE RICHARDS WRIST | Smith & Nephew Richards, Inc. | 1994-08-19 | 532 | 0 |
| K936233 | PELVIC RADIUS PLATE | Smith & Nephew Richards, Inc. | 1994-08-01 | 215 | 0 |
| K934733 | STIMULATING SURGICAL INSTRUMENTS | Smith & Nephew Richards, Inc. | 1994-07-20 | 292 | 0 |
| K941264 | RICHARD ROD LENS LARYNGOSCOPE | Smith & Nephew Richards, Inc. | 1994-07-18 | 124 | 0 |
| K930480 | VARIABLE ANGULAR HOLD BONE PLATE SYSTEM | Smith & Nephew Richards, Inc. | 1994-06-15 | 502 | 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