ClearanceBrief
Panels › Orthopedic › Product code JWH · Class 2

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Regulation 888.3560

14510(k)s in 12 months (921 all time)
7recalls in 12 months (985 all time)
888recalls that name a 510(k)
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Top companies in JWH

Company510(k)sRecalls
Zimmer, Inc.51304
DePuy Orthopaedics, Inc.16102
Smith & Nephew, Inc.4960
Exactech, Inc.3264
Howmedica Osteonics3261
Zimmer Biomet, Inc.085
Biomet, Inc.4044
Stryker Howmedica Osteonics064
Conformis, Inc.4019
Encore Medical L.P.1544
DateFirm and productCodeLinked 510(k)
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 83 mm Item # 195759
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 87 mm Item # 195760
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 91mm Item # 195761
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291
Terminated		 JWHK122160
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 91 mm Item # 195279
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 87 mm Item # 195278
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 83 mm Item # 195277
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 79 mm Item # 195276
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 75mm Item # 195275
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 73mm Item # 195274
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 71mm Item # 195273
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 69mm Item # 195272
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 67mm Item # 195271
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 65mm Item # 195270
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 63mm Item # 195269
Terminated		 JWHK132873
Aug 15, 2019Zimmer Biomet, Inc.
XP- CR Tibial Tray- Interlok 59mm Item # 195268
Terminated		 JWHK122160
May 30, 2019Ortho Development Corporation
Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
Open, Classified		 JWHK994370
May 30, 2019Ortho Development Corporation
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Open, Classified		 JWHK994370
Mar 13, 2019Exactech, Inc.
Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Kn
Terminated		 JWHK152170
Mar 1, 2019Zimmer Biomet, Inc.
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
Terminated		 JWHK912245
Mar 1, 2019Zimmer Biomet, Inc.
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
Terminated		 JWHK912245
Feb 1, 2019Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are inten
Terminated		 JWHK024161
Feb 1, 2019Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are inten
Terminated		 JWHK024161
Jan 4, 2019Conformis, Inc.
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Terminated		 JWHK161668
Dec 21, 2018Zimmer Biomet, Inc.
Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
Terminated		 JWHK171054
Dec 21, 2018Zimmer Biomet, Inc.
Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
Terminated		 JWHK040770
Dec 10, 2018Signature Orthopedics Pty Limited
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Terminated		 JWHK170613
Dec 10, 2018Signature Orthopedics Pty Limited
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Terminated		 JWHK170613
Dec 10, 2018Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNE
Terminated		 JWHK173331
Dec 10, 2018Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNE
Terminated		 JWHK173331
Dec 10, 2018Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNE
Terminated		 JWHK173331
Dec 10, 2018Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNE
Terminated		 JWHK173331
Dec 3, 2018Conformis, Inc.
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for
Terminated		 JWHK180906
Oct 31, 2018Zimmer Biomet, Inc.
NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be do
Terminated		 JWHK152494
Oct 22, 2018Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
Terminated		 JWHK023546
K113550
Oct 22, 2018Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Terminated		 JWHK023546
K113550
Oct 1, 2018Smith & Nephew, Inc.
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 7402312
Open, Classified		 JWHK042515
Oct 1, 2018Smith & Nephew, Inc.
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 7402112
Open, Classified		 JWHK042515
Oct 1, 2018Smith & Nephew, Inc.
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 7
Open, Classified		 JWHK042515
Aug 2, 2018Zimmer Biomet, Inc.
Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty
Terminated		 JWHK093293
Aug 2, 2018Zimmer Biomet, Inc.
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Terminated		 JWHK093293
Jul 18, 2018DePuy Orthopaedics, Inc.
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Terminated		 JWHK952830
Jun 4, 2018Zimmer Biomet, Inc.
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.
Terminated		 JWHK113550
K171054
Jun 1, 2018Zimmer Biomet, Inc.
Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty
Terminated		 JWHK010212
K142933 +2
Jun 1, 2018Zimmer Biomet, Inc.
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Terminated		 JWHK113550
K171054
May 14, 2018Encore Medical, Lp
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering f
Terminated		 JWHNone listed
May 8, 2018Exactech, Inc.
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due
Open, Classified		 JWHK150890
Apr 30, 2018DePuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Terminated		 JWHK160700
Apr 30, 2018DePuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Terminated		 JWHK160700

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