(90 days)
Not Found
No
The document describes a system of screws and accessories for bone fixation and does not mention any AI or ML capabilities.
Yes
The device is intended for "fixation of fracture, fusion and osteotomies," which are medical treatments aimed at repairing or aiding the healing of musculoskeletal issues. This directly aligns with the definition of a therapeutic device.
No
Explanation: The device, the Acumed Cannulated Screw System, is described as a system of screws, washers, and accessories intended for the "fixation of fracture, fusion and osteotomies." Its purpose is to physically stabilize and aid in the healing of bones, not to identify, detect, or monitor a medical condition.
No
The device description explicitly states that the system consists of screws, washers, and accessories made of titanium alloy, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of fractures, fusions, and osteotomies of bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as screws, washers, and accessories made of titanium alloy, designed for implantation into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / 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 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.
Product codes
HWC, OUR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large and small bones; wrist, ankle, elbow, shoulder, foot, tarsals, metatarsals, calcaneal, talar, fibula, malleolus, acetabular, pelvic ring, sacroiliac joint, femoral head and neck, distal femur, proximal tibia, patellar, tibial plateau, hand, carpals, metacarpals, ulna, radius, olecranon, distal humerus, humeral head, glenoid.
Indicated Patient Age Range
children
Pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical testing included in this submission includes testing to ASTM F543.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K021932, K962011, K111316, K983165, K120493, K102903
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, OUR | ||
| 888.3040 | Synthes 6.5 mm Cannulated Screw | Synthes (USA) | |
| K962011 | HWC | ||
| 888.3040 | Synthes 7.0/7.3 mm Cannulated | ||
| Screws | Synthes (USA) | ||
| K111316 | HWC | ||
| 888.3040 | aap Cannulated Screw | aap Implantate AG | |
| K983165 | HWC | ||
| 888.3040 | Osteo 4.0mm Cannulated Screw | ||
| System | Osteonics Corporation | ||
| K120493 | HWC | ||
| 888.3040 | Mini Cannulated Titanium Headed | ||
| and Headless Screw Set | Instratek, Inc. | ||
| K102903 | HWC, OUR | ||
| 888.3040 | Pioneer Cannulated Screw System | Pioneer Surgical | |
| Technology |
1
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.
Intended Use/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 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.
Substantial Equivalence Comparison
The basic comparison between the Acumed Cannulated Screw System and the predicate devices is given in the table below.
2
Acumed Cannulated Screw System 510(k) Notification
K123890 (pg 3/3)
| Predicate | Material | Diameter | Length | Cannulated | Provided
sterile /
non-sterile |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------|------------------|------------|--------------------------------------|
| Acumed
Cannulated Screw
System | Titanium alloy
per ASTM F136 | 3.0mm to
7.3mm | 8mm to
150mm | Yes | Sterile and
non-sterile |
| Synthes 6.5mm
Cannulated Screw | SS and Ti alloy | 6.5mm | 20mm to
200mm | Yes | Unknown |
| Synthes 7.0/7.3mm
Cannulated Screws | SS and Ti alloy | 7.0mm to
7.3mm | Unknown | Yes | Sterile |
| aap Cannulated
Screw | Ti alloy per
ASTM F136 or.
ISO 5832-2
SS per ASTM
F138 or ISO
5832-1 | 2.7mm to
7.5mm | Unknown | Yes | Unknown |
| Osteonics
Corporation
Osteo 4.0mm
Cannulated Screw
System | Titanium 6A1-4V
ELI alloy | 4.0mm | Unknown | Yes | Sterile and
non-sterile |
| Instratek Mini
Cannulated
Titanium Headed
and Headless
Screw Set | Titanium alloy
(Ti6AL4V) | 2.5mm to
4.0mm | Unknown | Yes | Unknown |
| Pioneer Cannulated
Screw System | Biodur 108 per
ASTM F2229 | 3.5mm to
7.5mm | 8mm to
200mm | Yes | Sterile and
non-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.
3
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
4
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
5
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