Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intermedics Orthopedics — Predicate Candidate Screening
108 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
427 days90th percentile
108clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970300 | NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI | Intermedics Orthopedics | 1997-07-03 | 160 | 0 |
| K970498 | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS | Intermedics Orthopedics | 1997-04-30 | 79 | 0 |
| K970166 | NATURAL-HIP SYSTEM COCR REVISION STEM | Intermedics Orthopedics | 1997-04-08 | 82 | 0 |
| K970567 | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS | Intermedics Orthopedics | 1997-02-27 | 14 | 0 |
| K964357 | NATURAL-HIP SYSTEM COCR STEM | Intermedics Orthopedics | 1997-01-27 | 87 | 0 |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | Intermedics Orthopedics | 1997-01-16 | 77 | 0 |
| K962190 | PATELLOFEMORAL JOINT PROSTHESIS | Intermedics Orthopedics | 1996-10-28 | 144 | 0 |
| K963266 | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED | Intermedics Orthopedics | 1996-10-15 | 56 | 0 |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | Intermedics Orthopedics | 1996-10-01 | 57 | 0 |
| K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | Intermedics Orthopedics | 1996-09-03 | 78 | 0 |
| K962289 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | Intermedics Orthopedics | 1996-08-29 | 76 | 0 |
| K962224 | SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS | Intermedics Orthopedics | 1996-08-28 | 79 | 0 |
| K962101 | ZWEYMUELLER SL FEMORAL HIP STEM | Intermedics Orthopedics | 1996-08-19 | 81 | 0 |
| K962238 | SELECT SHOULDER KEELED ALL-POLY GLENOIDS | Intermedics Orthopedics | 1996-08-09 | 59 | 0 |
| K962244 | SELECT SHOULDER PEGGED ALL-POLY GLENOID | Intermedics Orthopedics | 1996-08-09 | 59 | 0 |
| K961921 | APR OVERSIZED HIP STEM | Intermedics Orthopedics | 1996-08-05 | 80 | 0 |
| K960588 | WAGNER REVISION STEM | Intermedics Orthopedics | 1996-08-05 | 175 | 0 |
| K961727 | NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM | Intermedics Orthopedics | 1996-07-19 | 77 | 0 |
| K961799 | NATURAL HIP SYSTEM - DRG HIP STEM | Intermedics Orthopedics | 1996-07-15 | 67 | 0 |
| K960258 | NATURAL HIP SYSTEM | Intermedics Orthopedics | 1996-07-12 | 176 | 0 |
| K961589 | APR FULLY TEXTURED HIP STEM | Intermedics Orthopedics | 1996-07-09 | 76 | 0 |
| K953690 | CLS STEM (MODIFICATION) | Intermedics Orthopedics | 1996-06-07 | 312 | 0 |
| K960025 | PROTEK LOW PROFILE ACETABULAR CUP | Intermedics Orthopedics | 1996-06-07 | 157 | 1 |
| K960678 | BURCH/SCHNEIDER REINFORCEMENT CAGE | Intermedics Orthopedics | 1996-05-03 | 77 | 0 |
| K934695 | NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA | Intermedics Orthopedics | 1996-05-02 | 945 | 0 |
| K954800 | APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) | Intermedics Orthopedics | 1996-04-25 | 211 | 1 |
| K960535 | APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA | Intermedics Orthopedics | 1996-04-23 | 76 | 0 |
| K960626 | MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) | Intermedics Orthopedics | 1996-04-18 | 65 | 0 |
| K955739 | MODULAR ACETABULAR SHELL II | Intermedics Orthopedics | 1996-03-27 | 100 | 0 |
| K955778 | NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM | Intermedics Orthopedics | 1996-03-08 | 79 | 1 |
| K954854 | INTERMOORE FRACTURE HIP STEM | Intermedics Orthopedics | 1996-02-15 | 115 | 0 |
| K955033 | RIM FLARE ACETABULAR COMPONENT | Intermedics Orthopedics | 1996-01-31 | 90 | 0 |
| K935585 | APR ACETABULAR INSERTS IOI BIPOLAR | Intermedics Orthopedics | 1995-12-13 | 755 | 0 |
| K953688 | CLS ACETABULAR COMPONENT (MODIFICATION) | Intermedics Orthopedics | 1995-11-29 | 121 | 0 |
| K953689 | WAGNER REVISION STEM (MODIFICATION) | Intermedics Orthopedics | 1995-11-29 | 121 | 0 |
| K953578 | PROTEK ACETABULAR ROOF REINFORCEMENT RING | Intermedics Orthopedics | 1995-10-30 | 90 | 0 |
| K935523 | NATURAL-KNEE(R)/APOLLO(TM) KNEE | Intermedics Orthopedics | 1995-06-06 | 565 | 1 |
| K936159 | NATURAL-KNEE II SYSTEM | Intermedics Orthopedics | 1995-05-22 | 515 | 5 |
| K935802 | SELECT(R) SHOULDER ALL POLY GLENOID | Intermedics Orthopedics | 1995-05-22 | 536 | 0 |
| K950998 | MODUILAR UNIPOLAR | Intermedics Orthopedics | 1995-04-13 | 41 | 0 |
| K950027 | CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK | Intermedics Orthopedics | 1995-03-06 | 61 | 0 |
| K944529 | CABLE-EASE PLATE AND CABLE SYSTEM | Intermedics Orthopedics | 1995-02-17 | 155 | 0 |
| K945516 | NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM | Intermedics Orthopedics | 1995-02-14 | 97 | 0 |
| K934381 | APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT | Intermedics Orthopedics | 1995-02-08 | 518 | 1 |
| K935789 | POSTERIOR STABILIZED APOLLO KNEE SYSTEM | Intermedics Orthopedics | 1995-02-06 | 427 | 0 |
| K933229 | APOLLO KNEE FEMORAL COMPONENT | Intermedics Orthopedics | 1995-01-27 | 574 | 0 |
| K944209 | APR II NON POROUS HIP STEM | Intermedics Orthopedics | 1994-12-09 | 102 | 0 |
| K941617 | APR ACETABULAR INSERT | Intermedics Orthopedics | 1994-10-06 | 185 | 0 |
| K942406 | OPTION SHELL | Intermedics Orthopedics | 1994-10-05 | 138 | 0 |
| K942330 | APR II FEMORAL COMPONENT (VARIOUS) | Intermedics Orthopedics | 1994-10-04 | 141 | 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