Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sulzer Orthopedics, Inc. · Predicate Candidate Screening
45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
107 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022985 | ASCENDENT ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | 2002-12-05 | 87 | 1 |
| K021578 | NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE | Sulzer Orthopedics, Inc. | 2002-08-09 | 87 | 0 |
| K020713 | MS-30 LATERAL FEMORAL STEM | Sulzer Orthopedics, Inc. | 2002-05-14 | 70 | 1 |
| K013935 | ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS | Sulzer Orthopedics, Inc. | 2001-12-13 | 15 | 0 |
| K013031 | MOST OPTIONS SYSTEM | Sulzer Orthopedics, Inc. | 2001-12-07 | 88 | 3 |
| K012739 | CONVERGE ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | 2001-11-14 | 90 | 0 |
| K012961 | SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | 2001-10-18 | 44 | 0 |
| K011954 | SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE | Sulzer Orthopedics, Inc. | 2001-09-19 | 89 | 0 |
| K010839 | CLS VARUS STEM/CLS 135 STEM | Sulzer Orthopedics, Inc. | 2001-04-18 | 28 | 0 |
| K003758 | ALLOFIT ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | 2001-03-07 | 91 | 0 |
| K003801 | ANATOMICAL PRESS-FIT HUMERAL STEM | Sulzer Orthopedics, Inc. | 2001-02-28 | 82 | 1 |
| K003269 | UNICONDYLAR INTERPOSITIONAL SPACER | Sulzer Orthopedics, Inc. | 2001-01-04 | 78 | 0 |
| K003832 | SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM | Sulzer Orthopedics, Inc. | 2001-01-04 | 24 | 0 |
| K002575 | INTER-OP DURASUL ACETABULAR INSERTS (4MM) | Sulzer Orthopedics, Inc. | 2000-11-15 | 89 | 0 |
| K002356 | NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS | Sulzer Orthopedics, Inc. | 2000-10-30 | 89 | 0 |
| K002335 | NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL | Sulzer Orthopedics, Inc. | 2000-10-25 | 85 | 8 |
| K001536 | INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS | Sulzer Orthopedics, Inc. | 2000-07-27 | 71 | 0 |
| K001320 | SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM | Sulzer Orthopedics, Inc. | 2000-07-07 | 72 | 0 |
| K001078 | SULZER ORTHOPEDICS MS-30 FEMORAL STEM | Sulzer Orthopedics, Inc. | 2000-06-23 | 80 | 0 |
| K993259 | INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS | Sulzer Orthopedics, Inc. | 2000-03-10 | 163 | 3 |
| K993043 | MS-30 FEMORAL STEM | Sulzer Orthopedics, Inc. | 1999-12-02 | 83 | 0 |
| K974728 | INTER-OP METASUL ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | 1999-08-03 | 593 | 1 |
| K991143 | MAGNA-ROM 21 KNEE SYSTEEM | Sulzer Orthopedics, Inc. | 1999-06-11 | 67 | 0 |
| K990136 | ANATOMICA GLENOID COMPONENT | Sulzer Orthopedics, Inc. | 1999-03-01 | 46 | 2 |
| K990137 | ANATOMICA HUMERAL STEM/HEAD COMPONENTS | Sulzer Orthopedics, Inc. | 1999-02-18 | 35 | 0 |
| K983509 | INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT | Sulzer Orthopedics, Inc. | 1999-02-03 | 119 | 0 |
| K983592 | SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS | Sulzer Orthopedics, Inc. | 1999-01-28 | 107 | 0 |
| K983733 | SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL B | Sulzer Orthopedics, Inc. | 1998-12-18 | 57 | 0 |
| K983153 | NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TI | Sulzer Orthopedics, Inc. | 1998-12-04 | 86 | 1 |
| K982903 | SULZER ORTHOPEDICS FLUTED STEMS | Sulzer Orthopedics, Inc. | 1998-10-21 | 64 | 0 |
| K981211 | APR -T REVISION HIP STEM | Sulzer Orthopedics, Inc. | 1998-05-22 | 50 | 0 |
| K973837 | CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, | Sulzer Orthopedics, Inc. | 1998-01-06 | 90 | 0 |
| K973681 | NATURAL-HIP COCR OFFSET STEM | Sulzer Orthopedics, Inc. | 1997-12-19 | 84 | 0 |
| K973675 | NATURAL-HIP POROUS STEM WITH OFFSET | Sulzer Orthopedics, Inc. | 1997-12-19 | 84 | 0 |
| K973412 | NATURAL-KNEE II CONSTRAINED KNEE SYSTEM | Sulzer Orthopedics, Inc. | 1997-12-08 | 90 | 2 |
| K973087 | MOST HEX INTRAMEDULLARY (I/M) STEM | Sulzer Orthopedics, Inc. | 1997-11-14 | 88 | 0 |
| K973124 | APR POROUS HA HIP SYSTEM | Sulzer Orthopedics, Inc. | 1997-11-03 | 75 | 0 |
| K971523 | DISTALLY FIXED HIP STEM | Sulzer Orthopedics, Inc. | 1997-10-01 | 156 | 0 |
| K972501 | APOLLO REVISION/CONSTRAINED KNEE SYSTEM | Sulzer Orthopedics, Inc. | 1997-10-01 | 90 | 1 |
| K972637 | PRECEDENT REVISION HIP SYSTEM | Sulzer Orthopedics, Inc. | 1997-10-01 | 78 | 0 |
| K972393 | INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI) | Sulzer Orthopedics, Inc. | 1997-09-19 | 85 | 0 |
| K971715 | SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS | Sulzer Orthopedics, Inc. | 1997-08-07 | 90 | 0 |
| K971770 | APOLLO KNEE FEMORAL SPACERS | Sulzer Orthopedics, Inc. | 1997-07-31 | 79 | 0 |
| K970705 | INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES | Sulzer Orthopedics, Inc. | 1997-05-22 | 85 | 0 |
| K970706 | INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES | Sulzer Orthopedics, Inc. | 1997-05-22 | 85 | 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