(115 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any software-driven analysis or decision-making.
Yes.
The device is used to secure soft tissue to bone during reconstructive surgery for various injuries and conditions, which is a therapeutic intervention.
No
This device is a surgical fixation system used to secure soft tissue to bone during reconstructive surgery, not to diagnose a condition.
No
The device description explicitly states it is manufactured from stainless steel and titanium and describes physical components like screws and washers. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Surgicraft Screw Fixation System is a surgical implant used to physically secure soft tissue to bone during reconstructive surgery. It is a mechanical device used in vivo (within the body) during a surgical procedure.
- Intended Use: The intended use clearly describes a surgical procedure, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, the Surgicraft Screw Fixation System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Surgicraft Screw Fixation System and is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
Shoulder:
- Rotator Cuff Repair
- Bankart Repair
- SLAP Lesion Repair
- Acromio-Clavicular Separation Repair
- Capsular Shift/Capsulolabral Reconstruction
- Biceps Tenodesis
- Deltoid Repair.
Elbow. Wrist. Hand:
- Scapholunate Ligament Reconstruction
- Ulnar Collateral Ligament Reconstruction
- Radial Collateral Ligament Reconstruction
- Biceps Tendon Reattachment.
Foot and Ankle:
- Medial Instability Repair/Reconstruction
- Lateral Instability Repair/Reconstruction
- Achilles Tendon Repair/Reconstruction
- Midfoot Reconstruction
- Hallux Valgus Reconstruction.
Knee:
- Extra Capsular Repairs
o Medial Collateral Ligament
o Lateral Collateral Ligament
o Posterior Oblique Ligament - Illiotibial Band Tenodesis
- Patellar Tendon Repair.
Pelvis:
*Bladder Neck Suspension Procedures.
Single patient use only
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Surgicraft Screw Fixation System is manufactured from stainless steel and titanium. The self-tapping 3.5 mm screws are available in lengths from 20- 40 mm in 1 mm increments. The washers have an inner hole diameter of 4.2 mm and an outer diameter ranging from 7 to 9 mm in 1 mm increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Wrist, Hand, Foot, Ankle, Knee, Pelvis, Bone
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 Surgicraft Screw Fixation System was tested as follows:
• Mechanical Testing
ASTM - F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws
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.
K043185, K071157, K973775, K012572
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
Image /page/0/Picture/0 description: The image shows the text "K080447 (pg. 1 of 3)" at the top, followed by a double tilde symbol. Below that is the word "SURGICRAFT" in a bold, stylized font. The text appears to be part of a document or label, possibly indicating a product code or page number.
JUN 1 8 2008
510 (k) Summary
| A | |
|---|---|
| 510(k) Owner | Surgicraft Limited |
| 16 The Oaks | |
| Clews Road | |
| Redditch, Worchester | |
| England B98 7ST | |
| Contact | Donald W. Guthner |
| Orgenix, LLC | |
| 111 Hill Road | |
| Douglassville, PA 19518 | |
| (888) ORGENIX | |
| (484) 363-5879 (FAX) | |
| dg@orgenix.com | |
| Preparation Date | February 18, 2008 |
| B | |
| Trade Name | Surgicraft Screw Fixation System |
| Common Name | Fixation Bone Screw and Washer |
| Classification Name | 21 CFR 888.3040 |
| MBI | |
| Smooth or threaded metallic bone fixation fastener | |
| Class II | |
| C | |
| Predicate Device(s) | The subject device is substantially equivalent to similar previously cleared devices. Substantial equivalence for the Surgicraft Screw Fixation System is based on its similarities in indications for use, design features, operational principles and material composition when compared to the predicate devices cleared under the following submissions: |
| K043185 - Stryker 3.5mm Cortex ScrewsK071157 - Stryker Titanium Intraline AnchorK973775 - Biomet Harpoon Suture AnchorsK012572 - Biomet Soft Tissue Screws and Washers |
Surgicraft Limited / 16 The Oaks / Clews Road / Redditch / Worcestershire / UK / B98 7ST
Tel: +44 (0)1527 512600 / Fax: +44 (0)1527 551166 / Customer Service Fax: +44 (0)1527 512612 / E-mail: info@surgicraft.co.uk www.surgicraft.co.uk
e per per le se production and provincia de l'international de mail
App. 2 - 2
1
¥080447 2 of 3 (
| D | Device Description | The Surgicraft Screw Fixation System is manufactured from
stainless steel and titanium. The self-tapping 3.5 mm screws
are available in lengths from 20- 40 mm in 1 mm increments.
The washers have an inner hole diameter of 4.2 mm and an
outer diameter ranging from 7 to 9 mm in 1 mm increments. |
|---|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| E | Intended Use | The Surgicraft Screw Fixation System is a single-use, soft
tissue anchor which will be used to secure soft tissue to bone
during reconstructive surgery. The anchor is intended for
use in such procedures as:
Shoulder:
- Rotator Cuff Repair
- Bankart Repair
- SLAP Lesion Repair
- Acromio-Clavicular Separation Repair
- Capsular Shift/Capsulolabral Reconstruction
- Biceps Tenodesis
- Deltoid Repair.
Elbow. Wrist. Hand: - Scapholunate Ligament Reconstruction
- Ulnar Collateral Ligament Reconstruction
- Radial Collateral Ligament Reconstruction
- Biceps Tendon Reattachment.
Foot and Ankle: - Medial Instability Repair/Reconstruction
- Lateral Instability Repair/Reconstruction
- Achilles Tendon Repair/Reconstruction
- Midfoot Reconstruction
- Hallux Valgus Reconstruction.
Knee: - Extra Capsular Repairs
o Medial Collateral Ligament
o Lateral Collateral Ligament
o Posterior Oblique Ligament - Illiotibial Band Tenodesis
- Patellar Tendon Repair.
Pelvis:
*Bladder Neck Suspension Procedures. |
| F | Technological
Characteristics | As was established in this submission, the subject device is
substantially equivalent to other devices cleared by the
agency for commercial distribution in the United States. |
| G | Non-Clinical Testing | The Surgicraft Screw Fixation System was tested as follows:
• Mechanical Testing
ASTM - F543 - Standard Specification and Test
Methods for Metallic Medical Bone Screws |
| H | Clinical Testing | Not applicable to this device |
| I | Conclusions | Based on the 510(k) Summary and the information provided
herein, we conclude that the Surgicraft Screw Fixation
System is substantially equivalent to the existing legally
marketed devices under the Federal Food, Drug and
Cosmetic Act. |
| J | Additional Information | No additional information |
Engineering drawings, labeling, and mechanical testing have
2
K080447 (pg. 3 of 3)
demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2008
Surgicraft, Ltd. % Mr. Donald W. Guthner Orgenix, LLC 111 Hill Road Douglassville, Pennsylvania 19518
Rc: K080447
Trade/Device Name: Surgicraft Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: May 13, 2008 Received: May 14, 2008
Dear Mr. Guthner:
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.
4
Page 2 - Mr. Donald W. Guthner
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours.
Mark H. Milliman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devicesand Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): KO80447
Device Name: Surgicraft Screw Fixation System
Indications for Use:
The Surgicraft Screw Fixation System and is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
Shoulder:
- Rotator Cuff Repair 1 Bankart Repair * SLAP Lesion Repair * Acromio-Clavicular Separation Repair * Capsular Shift/Capsulolabral Reconstruction * Biceps Tenodesis * Deltoid Repair. Foot and Ankle: * Medial Instability Repair/Reconstruction * Lateral Instability Repair/Reconstruction * Achilles Tendon Repair/Reconstruction * Midfoot Reconstruction * Hallux Valgus Reconstruction.
Elbow. Wrist. Hand: * Scapholunate Ligament Reconstruction * Ulnar Collateral Ligament Reconstruction * Radial Collateral Ligament Reconstruction * Biceps Tendon Reattachment. Knce: * Extra Capsular Repairs -o Medial Collateral Ligament - Lateral Collateral Ligament - Posterior Oblique Ligament * Illiotibial Band Tenodesis * Patellar Tendon Repair. Pelvis: *Bladder Neck Suspension Procedures. Single patient use only
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Neil R.P. Ogle for xm
(Division Sign-Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K080447
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