Panels › Orthopedic › Product code HTY · Class 2
Pin, Fixation, Smooth
Regulation 888.3040
2510(k)s in 12 months (205 all time)
1recalls in 12 months (32 all time)
27recalls that name a 510(k)
Top companies in HTY
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 14 |
| Arthrex, Inc. | 13 | 0 |
| Biomet, Inc. | 5 | 2 |
| OSSIO , Ltd. | 6 | 0 |
| Synthes (Usa) | 5 | 0 |
| Bioretec, Ltd. | 4 | 0 |
| The Huxley Instrument Corp. | 4 | 0 |
| OrthoPediatrics Corp. | 4 | 0 |
| Paragon 28 | 3 | 1 |
| Smith & Nephew, Inc. | 1 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Arrowhead DE LLC Arrow-LOK Implant, REF:
21-253519,
21-253522,
21-253525,
21-253528,
21-253530,
21-253533,
21-253535,
21-253540,
21-253545,
21-253550,
21-353513,
21-353516,
27-253519,
27-253522,
27-253525,
27-253528, Open, Classified |
HTY | K112675 |
| Sep 19, 2024 | Smith & Nephew, Inc. DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener Open, Classified |
HTY | None listed |
| Sep 19, 2024 | Smith & Nephew, Inc. DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener Open, Classified |
HTY | None listed |
| May 26, 2022 | Paragon 28, Inc. HammerTube Implant, 2.75mm, 10 Cannulated (Sterile) Open, Classified |
HTY | K171715 |
| Mar 28, 2022 | Stryker GmbH Smart Toe II Intramedullary Arthrodesis Implant Open, Classified |
HTY | K112197 |
| Jan 28, 2022 | Brasseler USA, Medical L.L.C. Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S Terminated |
HTY | K945670 |
| Apr 1, 2020 | Trilliant Surgical, LLC 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225
(10)TSL007202 Terminated |
HTY | K121008 |
| Dec 11, 2019 | Brasseler USA I Lp Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm
Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures. Terminated |
HTY | K945670 |
| Jun 1, 2018 | Zimmer Biomet, Inc. 3.2MM X 560MM COCR THD TIP; 14-441053
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. RECON DRILL 6MM X 439MM; 14-443023
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. 3.2MM X 510MM COCR THD TIP; 14-443053
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. BEAD TIP GD WIRE 3.0MM X 60CM; 29402
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. G-PIN 2.8BL 3.2PL 98CM 2PK; 467260
NL DRIVING GUIDE 4.4MM X 80CM; 467220
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guide Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. G-PIN 2.8BL 3.2PL 98CM 2PK; 467260
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. G-PIN 2.8BL 3.2PL 60CM 2PK; 467265
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. BALL TIP GUIDE WIRE 2.0MMX60CM; 469020
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bon Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. BALL TIP GUIDE WIRE 3.2MMX55CM; 469055
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. BALL TIP GUIDE WIRE 3.2MMX98CM; 469060
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. DRILL PT GUIDE WIRE 2MM X 60CM; 469320
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Jun 1, 2018 | Zimmer Biomet, Inc. DRILL PT GUIDE WIRE 3.2MMX98CM, 469360
Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. Terminated |
HTY | K831005 |
| Mar 3, 2017 | MicroAire Surgical Instruments, LLC MicroAire K-Wires Terminated |
HTY | K863734 |
| Nov 22, 2016 | Amendia, Inc K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Num Terminated |
HTY | None listed |
| Oct 14, 2016 | Zimmer Biomet, Inc. Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK
Pin, Fixation, Smooth
A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A Terminated |
HTY | K831005 |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Pin, fixation, smooth. Terminated |
HTY | K831005 |
| Apr 25, 2014 | Acumed LLC The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. .
2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S
2.0 mm SS Sleeve Only; Part Number 01-0022-S
8, 7 hol Terminated |
HTY | K964500 |
| Sep 18, 2013 | Synthes USA HQ, Inc. Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device. Terminated |
HTY | K970733 |
| Sep 4, 2013 | MicroAire Surgical Instruments, LLC Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand F Terminated |
HTY | K863764 |
| Sep 4, 2013 | MicroAire Surgical Instruments, LLC Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Terminated |
HTY | K863764 |
| Aug 10, 2010 | Smith & Nephew Inc PERI-LOC, 2.0 MM X 228 MM, K-WIRE W/TROCAR POINT, CO-CR, REF 71173361, QTY: (6), STERILE FR, CE 0123, 2015/04, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttl Terminated |
HTY | None listed |
| Jun 26, 2009 | Zimmer Inc. Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6, nonsterile, qty 6, Zimmer, Warsaw, IN; Model Number: 00-0187-03-69.
Steinmann Pins are utilized in skeletal traction Terminated |
HTY | None listed |
| Oct 8, 2004 | Biomet, Inc. Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205. Terminated |
HTY | K990291 |
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