(88 days)
Not Found
No
The device description and intended use clearly describe a mechanical bone screw system, with no mention of software, algorithms, or any AI/ML related terms. The performance studies focus on mechanical properties like torque and pull-out force.
Yes.
The device is intended for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions, which falls under the definition of a therapeutic purpose for treating and restoring physiological function.
No
The device description and intended use clearly state that it is a surgical implant (bone screws) used for internal bone fixation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical screw made of titanium or stainless steel, intended for internal bone fixation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes the Arthrex Low Profile Screws as implants used for internal bone fixation in various anatomical locations. They are used to physically stabilize bone fractures, fusions, osteotomies, and non-unions.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Arthrex Low Profile Screws are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment Plates,
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as standalone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile and Small Fragment Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon; humerus, radius, ulna, tibia, calcaneous, femur and fibula.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS
Device Description
The Arthrex Low Profile Screw is fully or partially threaded, titanium or stainless steel, self-tapping, headed screw. The screw ranges from 2.0 mm to 4.0 mm in diameter and in length from 8 mm to 80 mm. The screw may be either solid or cannulated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, fibula
Indicated Patient Age Range
Not Found
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 submitted mechanical testing data demonstrated that the torque and pull-out force of the proposed devices is substantially equivalent to the torque and pull-out force of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K052614, K062863, K001941, K043185, K102343
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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MAR 1 8 2011
1 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | March 10, 2011 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Regulatory Affairs Project Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: csmith@arthrex.com | |
| Trade Name | Low Profile Screws |
| Common Name | Screw, fixation, bone |
| Product Code -Classification | |
| Name | |
| CFR | HWC, HRS |
| 21CFR 888.3030: Single/multiple component metallic bone | |
| fixation appliances and accessories | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation | |
| fastener. | |
| Predicate Device | K052614: Arthrex Low Profile Plate and Screw System |
| K062863: Osteomed Extended 2.0/2.4 Cannulated Screw System | |
| K001941: Synthes Modular Foot System | |
| K043185: Synthes 3.5mm Cortex Screws | |
| K102343: Cannulated Screw System | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to |
| obtain clearance for the Low Profile Screws. The Arthrex | |
| Low Profile Screws are a line extension of the Low Profile | |
| Screws cleared in K052614. | |
| Device Description and Intended | |
| Use | The Arthrex Low Profile Screw is fully or partially threaded, |
| titanium or stainless steel, self-tapping, headed screw. The | |
| screw ranges from 2.0 mm to 4.0 mm in diameter and in | |
| length from 8 mm to 80 mm. The screw may be either solid | |
| or cannulated. |
The Arthrex Low Profile Screws (2.0-3.0mm solid) are
intended to be used as stand-alone bone screws, or in a plate-
screw system for internal bone fixation for bone fractures,
fusions, osteotomies and non-unions in the ankle, foot, hand,
and wrist. When used with a plate, the screw may be used
with the Arthrex Low Profile and Small Fragment Plates. |
| | |
| | The Arthrex Low Profile Screws (2.0-3.0mm cannulated)
are intended to be used as stand-alone bone screws for
internal bone fixation for bone fractures, fusions, osteotomies
and non-unions in the ankle, foot, hand, and wrist. |
| | The Arthrex Low Profile Screws (3.5mm and larger, solid)
are intended to be used as stand-alone bone screws, or in a
plate-screw system for internal bone fixation for bone
fractures, fusions, osteotomies and non-unions in the ankle,
foot, hand, wrist, clavicle, scapula, olecranon, humerus,
radius, ulna, tibia, calcaneous, femur and fibula. When used
with a plate, the screws may be used with the Arthrex Low
Profile and Small Fragment Plates, Humeral Fracture Plates,
and Osteotomy Plates. |
| | The Arthrex Low Profile Screws (3.5mm and larger,
cannulated) are intended to be used as stand-alone bone
screws for internal bone fixation for bone fractures, fusions,
osteotomies and non-unions in the ankle, foot, hand, wrist,
clavicle, scapula, olecranon, humerus, radius, ulna, tibia,
calcaneous, femur and fibula. |
| Substantial Equivalence
Summary | The Low Profile Screws are substantially equivalent to the
predicate Osteomed Extended 2.0/2.4 Cannulated Screw
System, Synthes Modular Foot System, Synthes 3.5mm
Cortex Screw, and the previously cleared Arthrex Low Profile
Screws, in which the basic features and intended uses are the
same. Any differences between the Low Profile Screws and
the predicates are considered minor and do not raise questions
concerning safety and effectiveness. |
| | The proposed devices are composed of Titanium or Stainless
Steel that is substantially equivalent to the predicate devices. |
| | The submitted mechanical testing data demonstrated that the
torque and pull-out force of the proposed devices is
substantially equivalent to the torque and pull-out force of the
predicate devices. |
| | Based on the indication for use, technological characteristics.
and the comparison to the predicate devices, Arthrex, Inc. has
determined that the Low Profile Screws are substantially
equivalent to currently marketed predicate devices. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Ms. Courtney Smith 1370 Creekside Boulevard Naples, Florida 34108-1945
MAR 1 8 2011
Re: K103705
Trade/Device Name: Arthrex Low Profile Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, HRS Dated: February 16, 2011 Received: February 18, 2011
Dear Ms. Smith.
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, listing 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
3
Page 2 - Ms. Courtney Smith
forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Aty B. Duh
fen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1 Indications for Use Form
Indications for Use
510(k) Number (if known): K103705
Device Name: Arthrex Low Profile Screws
Indications For Use:
The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment Plates,
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as standalone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile and Small Fragment Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon; humerus, radius, ulna, tibia, calcaneous, femur and fibula.
Prescription Use _ V _ AND/OR Over-The-Counter Use _______ (Per 21 CFR 801 Subpart D) (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)
PAGE 1 of 1
for M. Melkerson
| (Division Sign-Off) |
|---|
| Division of Surgical, Orthopedic, and Restorative Devices |
| 510(k) Number | K103705 |
|---|---|
| --------------- | --------- |