Product code HWT— Orthopedic

FDA has cleared 10 devices under product code HWT between 1977 and 1998, filed by 9 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19981 clearance
• 19971 clearance
• 19901 clearance
• 19872 clearances
• 19831 clearance
• 19811 clearance
• 19781 clearance
• 19772 clearances

• Depuy, Inc.2 clearances
• Warsaw Orthopedic, Inc.1 clearance
• Shannon Group1 clearance
• Orthopedic Systems, Inc.1 clearance
• Ortho-Graphics, Inc.1 clearance
• Kronner Medical1 clearance
• Integrated Surgical Systems, Inc.1 clearance
• Biomet, Inc.1 clearance
• 3M Company1 clearance

Injury

218

Malfunction

12,907

Total

13,125

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K974406 — ORTHOPLANOrtho-Graphics, Inc.·1998-02-18
• K960685 — ORTHODOC PREOPERATIVE PLANNER MODEL 500Integrated Surgical Systems, Inc.·1997-01-17
• K894228 — KRONNER SPHERICAL CUTTERSKronner Medical·1990-07-23
• K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIAWarsaw Orthopedic, Inc.·1987-05-27
• K871323 — ARTHROSCOPIC MENISCAL SUTURE SYSTEMOrthopedic Systems, Inc.·1987-05-01
• K830360 — 3M OSTEOTOMY GUIDE3M Company·1983-03-01
• K811205 — MOLDED POLYSULFONE TRIAL PROSTHESISShannon Group·1981-05-21
• K781091 — KNEE INSTRUMENTATION, CONDYLARBiomet, Inc.·1978-07-17
• K771709 — WORRELL TRIAL PATELLADepuy, Inc.·1977-10-06
• K771710 — WORRELL PATELLA TEMPLATEDepuy, Inc.·1977-10-06