Product code JDG— Orthopedic
12-9170 SERIES II TOTAL HIP
- Classification name
- Prosthesis, Hip, Femoral Component, Cemented, Metal
- Device class
- Class 2
- Regulation
- 21 CFR 888.3360
- Advisory panel
- Orthopedic
- Total cleared
- 59
- First cleared
- Most recent
Market context for product code JDG
FDA has cleared devices under product code JDG between 1976 and 2022, filed by 26 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2020
- 2018
- 2000
- 1999
- 1996
- 1995
- 1994
- 1993
- 1991
- 1988
- 1987
- 1985
- 1983
- 1981
Top applicants under product code JDG
Adverse events under product code JDG
product code JDG- Injury
- 804
- Malfunction
- 3,242
- Total
- 4,046
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code JDG
- K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
- K193546 — Distal Centralizers
- K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
- K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
- K992234 — THE TAPER-FIT TOTAL HIP SYSTEM
- K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
- K955171 — NEXLOCK FEMORAL STEM
- K953653 — LUBINUS SP II HIP SYSTEM
- K953067 — HIP FRACTURE STEM FENESTRATION PLUG
- K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM
- K951083 — PROFORM CEMENTED FEMORAL COMPONENT
- K942479 — INTEGRAL CO-CR FEMORAL COMPONENT
- K942027 — IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
- K942028 — RX90 FEMORAL COMPONENT
- K931194 — CO-CR ANSWER FEMORAL COMPONENT
- K935078 — S-ROM TOTAL HIP REPLACEMENT SYSTEM
- K933871 — BRIDGE(TM) HIP SYSTEM
- K915385 — PPC HIP STEM COMPONENT
- K915391 — FPC HIP STEM COMPONENT
- K924099 — UFC HIP STEM COMPONENT
- K915787 — STABILITY HIP STEM WITH POROCOAT
- K922682 — AMERICANA HIP PROTHESIS
- K911595 — INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE
- K874868 — OPTI-FIX COLLARED FEMORAL COMPONENTS
- K874575 — PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
- K874100 — AML CALCAR FEMORAL PROSTHESIS
- K873627 — CTI STRAIGHT STEM
- K874740 — WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO
- K874617 — THOMPSON HIP PROSTHESIS
- K873458 — HOWMEDICA PCA COLLARED FEMORAL STEM
- K873089 — PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
- K851566 — HOWMEDICA FEMORAL COMPONENT HIP SYS 6259
- K833468 — BDH UNIVERSAL HIP SYSTEM SURGEON
- K812669 — SEATTLE II TOTAL HIP SYSTEM
- K812687 — BRIGHAM II TOTAL HIP SYSTEM
- K801006 — CHARNLEY DESIGN HIP PROSTHESIS
- K800051 — HEXCEL FEMORAL COMPONENT HIP PROSTHESIS
- K800050 — ANITOMIC TOTAL HIP SYSTEM
- K792329 — BIOPHASE IMPLANT MATERIAL
- K780773 — PROSTHESIS, HIP, CATHCART, SCHILLER MOD.
- K780497 — SPHERISTEM TOTAL HIP PROSTHESIS
- K780357 — TITANIUM MULLER TOTAL HIP
- K780329 — TOTAL HIP, NEW ENGLAND BAPTIST
- K772120 — TOTAL HIP, CHARNELY TYPE
- K770471 — KERBOULL-CHARNLEY CUP SPECIAL MODEL
- K770473 — LAGRANGE LETOURNEL TOTAL HIP FEMORAL
- K770219 — WATSON-FARRAR TOTAL HIP REPLACEMENT
- K770184 — BI-CENTRIC ENDOPROSTHESES
- K770161 — MICROFENESTRATED HIP REPLACEMENT COMPON.
- K761146 — SPARBARO TYPE TOTAL HIP
- K761243 — 12-9170 SERIES II TOTAL HIP
- K761002 — CHARNLEY CONGENITAL HIP FEMUR (85-3060)
- K761003 — CHARNLEY CONGENITAL HIP FEMUR (85-3061)
- K760974 — CHARNLEY FEMORAL COMPONENT
- K760976 — CHARNLEY REVISION SET
- K760651 — TOTAL HIP REPLACEMENT,LAGRANGE-LETOURNEL
- K760106 — PROSTHESIS, TOTAL HIP-FEMORAL
- K760107 — PROSTHESIS, TOTAL HIP-TEST FEMORAL
- K760108 — PROSTHESIS, TOTAL HIP-TEST CUP
Data sourced from openFDA. This site is unofficial and independent of the FDA.