Product code KIH— Orthopedic

FDA has cleared 11 devices under product code KIH between 1978 and 2004, filed by 7 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.

• 20041 clearance
• 19941 clearance
• 19901 clearance
• 19851 clearance
• 19841 clearance
• 19831 clearance
• 19811 clearance
• 19801 clearance
• 19791 clearance
• 19782 clearances

• Howmedica Corp.3 clearances
• Johnson & Johnson Professionals, Inc.2 clearances
• Dentsply Intl.2 clearances
• Zimmer, Inc.1 clearance
• Precision Medical Devices, Inc.1 clearance
• DePuy Orthopaedics, Inc.1 clearance
• Depuy, Inc.1 clearance

Death

3

Total

3

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 →

• K042591 — SMARTMIX PRE-FILLED MIXING SYSTEMDePuy Orthopaedics, Inc.·2004-10-22
• K943906 — P.F.C. CEMENT PRESSURIZING SYSTEMJohnson & Johnson Professionals, Inc.·1994-12-21
• K897134 — CMW CEMENT PRESSURISATION SYSTEMDentsply Intl.·1990-03-02
• K851881 — ORTHOPEADIC CEMENT DELIVERY SYSTEMDentsply Intl.·1985-06-13
• K840046 — PRESSURIZING/SCAVENGING ACRYLIC CEMENTPrecision Medical Devices, Inc.·1984-02-09
• K833675 — BRIGHAM TIBIAL CEMENT PRESSURIZERHowmedica Corp.·1983-12-12
• K811317 — HOWMEDICA FEMORAL PRESSURING SEALHowmedica Corp.·1981-05-29
• K801388 — OH-HARRISJohnson & Johnson Professionals, Inc.·1980-07-28
• K790275 — GUN, EXETER CEMENTHowmedica Corp.·1979-02-21
• K781955 — GUN, CEMENTDepuy, Inc.·1978-12-04
• K780266 — BONE CEMENT APPLICATORZimmer, Inc.·1978-02-28