(213 days)
Not Found
No
The document describes a purely mechanical, bioabsorbable screw system for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies section explicitly states that performance data, clinical, and non-clinical tests are not applicable, which is inconsistent with a device incorporating AI/ML that would require validation studies.
Yes.
The device is intended to provide fixation and/or reduction of bone fragments and bones, which is a therapeutic function addressing musculoskeletal issues.
No
The device is a surgical screw system used for fixation and reduction of bone fragments. It treats conditions rather than diagnosing them.
No
The device description explicitly states it is composed of screws injection molded from poly-L-lactic acid (PLLA), which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "bioabsorbable PLLA screw intended to provide fixation and/or reduction of bone fragments and bones." This describes a surgical implant used directly on the patient's body to treat a physical condition.
- Device Description: The description details a physical screw made of PLLA, designed for surgical implantation.
- 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 screening.
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 ARC Surgical Resorbable Compression Screw is a bioabsorbable PLLA screw intended to provide fixation and/or reduction of bone fragments and bones. Specifically, as listed below, the screw is intended to fix osteochondral fragments, osteotomies and fractures in the foot, and limited fractures in the wrist, elbow, and ankle.
- . Osteochondral fragments
- Femoral condyle o
- Talus 0
- Navicular ्
- Hallux Valgus correction ●
- Tarsal fractures .
- Distal Radius fractures ●
- Radial Head fractures .
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The ARC Surgical Resorbable Compression Screw System is composed of screws injection molded from poly-L-lactic acid (PLLA) with diameter (4.3mm to 4.8mm) and length (16mm to 24mm). Headless screw compression is obtained from the varying pitch of the threadless screw has a tapered square cannulation and the driver has a square-shaped geometry to drive the screw. The screws are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, wrist, elbow, ankle (Specifically: Femoral condyle, Talus, Navicular, Hallux Valgus, Tarsal, Distal Radius, Radial Head)
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)
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
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.
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.
0
K043176 pg. 1 of 2
JUN 1 7 2005
ARc SURGICAL LLCr
5885 N.W. Cornelius Pass Road Suite 100 Hillsboro, Oregon 97124
Tel (503) 645-9300
510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information: Arc Surgical LLC 5885 N.W. Cornelius Pass Road, Suite 100 Hillsboro, OR 97124 USA Phone: (503) 645-9300 FAX: (503)645-9304 Contact: Ed Boehmer, Regulatory Supervisor
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
|---|---|
| Common Name: | Screw, Fixation, Bone |
| Proprietary Name: | Arc Surgical Resorbable Compression Screw System |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3040 |
| Device Product Code: | HWC |
| Legally Marketed Equivalent Device(s): | Arthrex Bio-Compression Screw K032098 |
| Bionx Smart Screw K003077 | |
| Biomet ReUnite Bone Screw K992301 |
Device Description: The ARC Surgical Resorbable Compression Screw System is composed of screws injection molded from poly-L-lactic acid (PLLA) with diameter (4.3mm to 4.8mm) and length (16mm to 24mm). Headless screw compression is obtained from the varying pitch of the threadless screw has a tapered square cannulation and the driver has a square-shaped geometry to drive the screw. The screws are provided sterile.
Intended Use: The ARC Surgical Resorbable Compression Screw is a bioabsorbable PLLA screw intended to provide fixation and/or reduction of bone fragments and bones. Specifically, as listed below, the screw is intended to fix osteochondral fragments, osteotomies and fractures in the foot, and limited fractures in the wrist, elbow, and ankle.
- . Osteochondral fragments
- Femoral condyle o
- Talus 0
- Navicular ্
- Hallux Valgus correction ●
- Tarsal fractures .
- Distal Radius fractures ●
- Radial Head fractures .
These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
1
K043176 page 2 of 2
Technological Characteristics: The screws are being injection molded from PLLA pellets (Boehringer-Ingleheim Resomer 210S). The PLLA pellets are polymerized from L-lactide monomers through the process of ring-opening polymerization. Stannous (tin) octoate is utilized as the catalyst. The predicates devices listed use either PLLA or LactoSorb (82% PLLA/18%PGA).
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Based upon the similarities of the ARC Surgical Resorbable Compression Screw System and the predicate devices studied, the safety and effectiveness of the ARC Surgical Resorbable Compression Screw System is substantially equivalent to the predicate devices referenced.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Public Health Service
JUN 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ed Boehmer ARC Surgical LLC 5885 N.W. Cornelius Pass Road, Suite 100 Hillsboro, Oregon 97229
Re: K043176
Trade/Device Name: Arc Surgical Resorbable Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 9, 2005 Received: May 10, 2005
Dear Mr. Boehmer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 – Mr. Ed Boehmer
This letter will allow you to begin marketing your device as described in your Section 510(k) I this letter will anow you to oegin manteeing your antial equivalence of your device to a legally premits et notheation. The PDA miaing of casification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac not 2011-01-20 2017 - 120 - 120 - 12-2 - 12 "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Misorallumg by Iciercice to premation nothilities under the Act may be obtained from the Other general information on Joan responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Signature
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1 Page of
K043176 510(k) Number (if known): _
Arc Surgical Resorbable Compression Screw System Device Name: _
Indications For Use:
System is intended to fix The Arc Surgical Resorbable Compression Screw The Arc Surgical Resorband Collipression "Ocrow" - System" - System" - 12
osteochondral fragments, osteotonies and fractures in the foot, and limited fractures in the wrist, elbow, and ankle, as listed:
- Osteochondral fragments .
- o Femoral condyle
- Talus o
- o Navicular
- Hallux Valgus correction .
- Tarsal fractures .
- Distal Radius fractures .
- Radial Head fractures .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
No Over-The-Counter Use _ (Part 21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
ាំនចោ និង ១-Of Cision of General Gestorative d Neurological Levices
0431