The Acumed Cannulated Screw System consists of screws, washers, and accessories and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for size of device, which may include the following: Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures; Multifragment joint fractures: Simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder; Condylar fractures; Epiphyseal and metaphyseal fractures in children; Osteochrondritis dissecans; Ostero-Chondral Fractures; Ligament avulsion injuries; Ligament fixation; Other small fragment, cancellous bone fractures; Small joint fusion; Areas where accurate screw placement is vital; Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and fractures of metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures; Subtalar arthrodesis; Ankle arthrodesis; Fractures of small joints, such as: Ankle fractures, Navicular fractures of the fibula, malleolus, and calcaneus; Distal tibia and pilon fractures; Acetabular fractures; Other fractures of the pelvic ring; Sacroiliac joint disruptions; Fractures of the femoral head and neck; Supracondylar femoral fractures; Slipped capital femoral epiphyses: An adjunct to DHS in basilar neck fractures; Pediatric femoral neck fractures; Intercondylar femur fractures; Intracapsular fractures of the hip; Fractures of the distal femur and proximal tibia; Patellar fractures; Tibial plateau fractures; Small fragments of the hand and wrist; Fractures of the carpals and metacarpals; Carpal and metacarpal arthrodesis; Scaphoid fracture and other fractures of the hand; Phalangeal and interphalangeal fractures; Fractures of the ulna and radius; Radial head fractures; Fractures of the olecranon and distal humerus; Humeral head fractures; Ligament fixation at the proximal humerus; and Glenoid fractures. Washers may be used with the screws in certain applications.

Device Description

The Acumed Cannulated Screw System consists of screws, washers, and accessories used for fixation of fracture, fusion and osteotomies of large and small bones appropriate for the size of the device.

Screws are available in a variety of diameters and lengths to accommodate various indications and patient anatomy. All screws and washers are made of titanium alloy per ASTM F136. Screws range in diameter from 3.0mm to 7.3mm and in lengths from 8mm to 150mm.

All implants are provided sterile and non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Acumed Cannulated Screw System), not a clinical study report. Therefore, it does not contain information about acceptance criteria for device performance, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on establishing "substantial equivalence" of the Acumed Cannulated Screw System to legally marketed predicate devices, as required for 510(k) clearance by the FDA. This process relies on demonstrating that a new device is as safe and effective as pre-existing, legally marketed devices.

Specifically, the document mentions:

Non-clinical Testing: "The non-clinical testing included in this submission includes testing to ASTM F543." This indicates that the device underwent engineering/material testing according to an industry standard, but it doesn't provide performance metrics against acceptance criteria for clinical outcomes nor details of a study with human subjects or expert assessment.
Substantial Equivalence Comparison: A table compares the Acumed system to predicate devices based on material, diameter, length, cannulation, and sterility. The conclusion states, "There are some differences, but none of them raise new issues of safety or effectiveness. The Acumed Cannulated Screw System is substantially equivalent to the predicate devices."

Therefore, I cannot provide the requested information because the document does not contain a study that describes acceptance criteria or provides performance data in the context of a clinical or analytical validation study involving human data, expert review, or ground truth establishment.

Summary

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K123890 (pg 1/3)

Acumed Cannulated Screw System 510(k) Notification

510(k) Summary

MAR 1 8 2013

Contact Details

Applicant Name:

Acumed LLC 5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432

Kara Budor, Regulatory Specialist 503-207-1412

Date Prepared: December 17, 2012

Device Name

Trade Name: Acumed Cannulated Screw System

Common Name: Cannulated Screw

Classification: 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.

Class: II

Product Code: HWC, OUR

Legally Marketed Predicate Device(s)

There are six predicate devices. The comparison is to the Synthes 6.5 mm Cannulated Screw, the Synthes 7.0/7.3 mm Cannulated Screws, the aap Cannulated Screw, the Osteonics Osteo 4.0mm Cannulated Screw System, the Instratek Mini Cannulated Titanium Headed and Headless Screw Set, and the Pioneer Cannulated Screw System.

510(k) Number	Product Code	Trade Name	Applicant
K021932	HWC, OUR888.3040	Synthes 6.5 mm Cannulated Screw	Synthes (USA)
K962011	HWC888.3040	Synthes 7.0/7.3 mm CannulatedScrews	Synthes (USA)
K111316	HWC888.3040	aap Cannulated Screw	aap Implantate AG
K983165	HWC888.3040	Osteo 4.0mm Cannulated ScrewSystem	Osteonics Corporation
K120493	HWC888.3040	Mini Cannulated Titanium Headedand Headless Screw Set	Instratek, Inc.
K102903	HWC, OUR888.3040	Pioneer Cannulated Screw System	Pioneer SurgicalTechnology

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Device Description

The Acumed Cannulated Screw System consists of screws, washers, and accessories used for fixation of fracture, fusion and osteotomies of large and small bones appropriate for the size of the device.

All implants are provided sterile and non-sterile.

Intended Use/Indications for use

Substantial Equivalence Comparison

The basic comparison between the Acumed Cannulated Screw System and the predicate devices is given in the table below.

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Acumed Cannulated Screw System 510(k) Notification

K123890 (pg 3/3)

Predicate	Material	Diameter	Length	Cannulated	Providedsterile /non-sterile
AcumedCannulated ScrewSystem	Titanium alloyper ASTM F136	3.0mm to7.3mm	8mm to150mm	Yes	Sterile andnon-sterile
Synthes 6.5mmCannulated Screw	SS and Ti alloy	6.5mm	20mm to200mm	Yes	Unknown
Synthes 7.0/7.3mmCannulated Screws	SS and Ti alloy	7.0mm to7.3mm	Unknown	Yes	Sterile
aap CannulatedScrew	Ti alloy perASTM F136 or.ISO 5832-2SS per ASTMF138 or ISO5832-1	2.7mm to7.5mm	Unknown	Yes	Unknown
OsteonicsCorporationOsteo 4.0mmCannulated ScrewSystem	Titanium 6A1-4VELI alloy	4.0mm	Unknown	Yes	Sterile andnon-sterile
Instratek MiniCannulatedTitanium Headedand HeadlessScrew Set	Titanium alloy(Ti6AL4V)	2.5mm to4.0mm	Unknown	Yes	Unknown
Pioneer CannulatedScrew System	Biodur 108 perASTM F2229	3.5mm to7.5mm	8mm to200mm	Yes	Sterile andnon-sterile

The Acumed Cannulated Screw System, the Synthes 6.5 mm Cannulated Screw, the Synthes 7.0/7.3 mm Cannulated Screws, the aap Cannulated Screw, the Osteonics Osteo 4.0mm Cannulated Screw System, the Instratek Mini Cannulated Titanium Headed and Headless Screw Set, and the Pioneer Cannulated Screw System are all sets of cannulated screws which are used to achieve fixation. There are some differences, but none of them raise new issues of safety or effectiveness. The Acumed Cannulated Screw System is substantially equivalent to the predicate devices.

Non-clinical Testing

The non-clinical testing included in this submission includes testing to ASTM F543.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold font. The text is centered in the image. The text is likely the name of a government agency.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2013

Acumed LLC % Ms. Kara Budor Regulatory Specialist 5885 Northwest Cornelius Pass Road Hillsboro, Oregon 97124

Re: K123890

Trade/Device Name: Acumed Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, OUR Dated: December 17, 2012 Received: December 18, 2012

Dear Ms. Budor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Ms. Kara Budor

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/4/Picture/7 description: The image shows the name "Erin I.D. Keith" in a stylized font. The first name "Erin" is in a bold, sans-serif font. The middle initial "I.D." is in a more decorative font with concentric circles and lines. The last name "Keith" is in a similar style to the middle initial, with concentric circles and lines.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Acumed Cannulated Screw System 510(k) Notification

Indications for Use

510(k) Number (if known); K123890 (pg 1/1)

Device Name: Acumed Cannulated Screw System

Indications for Use:

The Acumed Cannulated Screw System consists of screws, washers, and accessories and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for size of device, which may include the following: Minimally invasive reconstruction of fractures and joints: Adjuvant for osteosynthesis in complex joint fractures; Multifragment joint fractures: Simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder; Condylar fractures; Epiphyseal fractures in children; Osteochrondritis dissecans; Ostero-Chondral Fractures; Ligament avulsion injuries; Ligament fixation; Other small fragment, cancellous bone fractures; Small joint fusion; Areas where accurate screw placement is vital; Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures of metatarsal V: Tarso-metatarsal and metatarso-phalangeal arthrodesis: Tarsal Fusions: Calcaneal and talar fractures; Subtalar arthrodesis; Ankle arthrodesis; Fractures of small joints, such as: Ankle fractures, Navicular fractures of the fibula, malleolus, and calcaneus: Distal tibia and pilon fractures: Acetabular fractures: Other fractures of the pelvic ring; Sacroiliac joint disruptions; Fractures of the femoral head and neck: Supracondylar femoral fractures; Slipped capital femoral epiphyses; An adjunct to DHS in basilar neck fractures; Pediatric femoral neck fractures; Intercondylar femur fractures; Intracapsular fractures of the hip; Fractures of the distal femur and proximal tibia; Patellar fractures; Tibial plateau fractures; Small fragments of the hand and wrist; Fractures of the carpals and metacarpals; Carpal and metacarpal arthrodesis; Scaphoid fracture and other fractures of the hand; Phalangeal and interphalangeal fractures; Fractures of the ulna and radius; Radial head fractures: Fractures of the olecranon and distal humerus: Humeral head fractures: Ligament fixation at the proximal humerus; and Glenoid fractures. Washers may be used with the screws in certain applications.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D).

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth Frank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.