Panels › Orthopedic › Product code LXH · Class 1
Orthopedic Manual Surgical Instrument
Regulation 888.4540
0510(k)s in 12 months (58 all time)
8recalls in 12 months (526 all time)
20recalls that name a 510(k)
Top companies in LXH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2026 | United Orthopedic Corp. Brand Name: U2 Total Knee System
Product Name: Femoral offset bushing, 2mm and 6mm
Model/Catalog Number: 9323-5312
Software Version: N/A
Product Description: Manual Orthopedic Surgical Instrument
Comp Open, Classified |
LXH | None listed |
| Aug 5, 2026 | United Orthopedic Corp. Brand Name: U2 Total Knee System
Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right
Model/Catalog Number: 9323-5335, 9323-5337, 93 Open, Classified |
LXH | None listed |
| Aug 5, 2026 | United Orthopedic Corp. Brand Name: U2 Total Knee System
Product Name: Femoral valgus adaptor, left and right
Model/Catalog Number: 9323-5333 and 9323-5334
Software Version: N/A
Product Description: Manual Orthopedic Surgica Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475640
Product Description: Intramedullary Bone Saw Blade Assembly 16mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475635
Product Description: Intramedullary Bone Saw Blade Assembly 15mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475630
Product Description: Intramedullary Bone Saw Blade Assembly 14mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475625
Product Description: Intramedullary Bone Saw Blade Assembly 13mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475620
Product Description: Intramedullary Bone Saw Blade Assembly 12mm Open, Classified |
LXH | None listed |
| Apr 17, 2025 | Stryker GmbH Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; Open, Classified |
LXH | None listed |
| Apr 17, 2025 | Stryker GmbH Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; Open, Classified |
LXH | None listed |
| Mar 11, 2025 | DePuy Mitek, Inc., a Johnson & Johnson Co. COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. Open, Classified |
LXH | None listed |
| Mar 11, 2025 | DePuy Mitek, Inc., a Johnson & Johnson Co. COR Disposable Kit, 8 mm. Cartilage Transplant System. Open, Classified |
LXH | None listed |
| Jan 22, 2025 | Integrity Implants Inc. Brand Name: N/A
Product Name: Repeater Bone Tamp
Model/Catalog Number: ASY-00132
Software Version: N/A
Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft materi Open, Classified |
LXH | None listed |
| Nov 27, 2024 | Gauthier Biomedical, Inc. TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509) Open, Classified |
LXH | None listed |
| Oct 17, 2024 | Spineology, Inc. The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deplo Open, Classified |
LXH | None listed |
| Sep 24, 2024 | Waldemar Link GmbH & Co. KG (Corp. Hq.) LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01 Open, Classified |
LXH | None listed |
| Aug 29, 2024 | ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System Open, Classified |
LXH | K041393 |
| Aug 20, 2024 | Intrinsic Therapeutics, Inc. Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A Open, Classified |
LXH | None listed |
| Jun 18, 2024 | Howmedica Osteonics Corp. Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910 Open, Classified |
LXH | None listed |
| Jun 18, 2024 | Howmedica Osteonics Corp. HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 Open, Classified |
LXH | None listed |
| Feb 6, 2024 | Howmedica Osteonics Corp. HRIS ACET CUP CUT TIP 32X140
Part Number: 6210-5-200rker.
single-use, sterile surgical instruments used during hip arthroplasty Open, Classified |
LXH | None listed |
| Feb 6, 2024 | Howmedica Osteonics Corp. HRIS ACET CUP CUT TIP 26X140
Part Number: 6210-5-100.
single-use, sterile surgical instruments used during hip arthroplasty Open, Classified |
LXH | None listed |
| Dec 26, 2023 | Acumed LLC RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320
The RBL2320, Low Profile Primary Guide is an instrument used with a power system to
compress the RibLoc plates onto the bone, d Open, Classified |
LXH | None listed |
| Dec 21, 2023 | Stryker Spine LITe Decompression Snake Arm, REF 48080230 Open, Classified |
LXH | None listed |
| Aug 29, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure
Item Number: 17-5220/01 Open, Classified |
LXH | None listed |
| Jul 3, 2023 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Part Number Open, Classified |
LXH | None listed |
| Jul 3, 2023 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Part Number Open, Classified |
LXH | None listed |
| Jul 3, 2023 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Part Number Open, Classified |
LXH | None listed |
| Jul 3, 2023 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Part Number: Open, Classified |
LXH | None listed |
| Jun 14, 2023 | Howmedica Osteonics Corp. Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 Open, Classified |
LXH | None listed |
| May 10, 2023 | Medtronic Sofamor Danek USA Inc Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery Open, Classified |
LXH | None listed |
| Jun 29, 2022 | SONEX HEALTH LLC SX-One MicroKnife Terminated |
LXH | K192873 |
| May 3, 2022 | Tornier, Inc Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit Open, Classified |
LXH | K161742 |
| Apr 29, 2022 | restor3d Inc. Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument Terminated |
LXH | None listed |
| Apr 29, 2022 | restor3d Inc. Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument Terminated |
LXH | None listed |
| Apr 29, 2022 | restor3d Inc. Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument Terminated |
LXH | None listed |
| Apr 13, 2022 | Medacta Usa Inc GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 Terminated |
LXH | None listed |
| Mar 25, 2022 | Arthrex, Inc. K-Wire, 1.35 mm x 170 mm Terminated |
LXH | None listed |
| Dec 22, 2021 | Synthes (USA) Products LLC Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nail Open, Classified |
LXH | None listed |
| Aug 18, 2021 | In2bones USA, LLC CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures. Terminated |
LXH | None listed |
| Jul 29, 2021 | Mizuho OSI HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 Open, Classified |
LXH | None listed |
| Jul 2, 2021 | Laboratoires Bodycad, Inc. Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004. Terminated |
LXH | None listed |
| Mar 26, 2021 | ConMed Corporation KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100.
For use in open and arthroscopic procedures for knee ligament rec Terminated |
LXH | None listed |
| Mar 26, 2021 | ConMed Corporation INFINITY_TRAY Custom Procedural Kit - Canada.
containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament recons Terminated |
LXH | None listed |
| Nov 18, 2020 | Aesculap Implant Systems LLC ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R Terminated |
LXH | None listed |
| Nov 12, 2020 | ConMed Corporation Infinity ACL Tibial Tip Guide-
indicated for use in open and arthroscopic procedures for knee ligament reconstruction.
Catalog Number: KTT100 Terminated |
LXH | None listed |
| Nov 12, 2020 | ConMed Corporation Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction.
Catalog Number: KTE100 Terminated |
LXH | None listed |
| Nov 4, 2020 | K2M, Inc Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from th Terminated |
LXH | None listed |
| Jul 13, 2020 | Aesculap Implant Systems LLC ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R Terminated |
LXH | None listed |
| Jun 29, 2020 | Smith & Nephew, Inc. PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicat Terminated |
LXH | None listed |
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