(662 days)
No
The device description and performance studies focus on the mechanical properties and materials of a surgical fixation device, with no mention of AI or ML technologies.
Yes
The device is intended to provide fixation during the healing process following a syndesmotic trauma, which directly refers to treating or healing a medical condition, aligning with the definition of a therapeutic device.
No
The device is described as providing "fixation during the healing process" for syndesmotic trauma, indicating it is a therapeutic device for structural support, not for diagnosis.
No
The device description explicitly states it is a combination of two physical medical devices (mesh and screw) made from materials like polyester, stainless steel, and titanium alloy. There is no mention of software components.
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, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is an implantable medical device designed to provide mechanical fixation within the body during the healing process of a specific joint injury. It is a physical device used for surgical repair.
The description clearly indicates it's a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is a combination of two FDAcleared Surgicraft Products, the Surgicraft LOCKDOWN Mesh (K072370) and the Surgicraft LOCKDOWN Screw (K080447). The new product for this indication is designated as the LOCKDOWN™ Acromioclavicular (AC) device and will have a new indication to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
It is not intended that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device be used as the sole means of reconstructing a chronic acromioclavicular joint dislocation.
The Surgicraft LOCKDOWN Mesh device is a woven mesh 11mm wide by 4 to 20 cm in length with loops at both ends. The Surgical Mesh is made from braided Polyethyleneterephthalate (Polyester) fibers (PET).
The Surgicraft LOCKDOWN Screw is manufactured from stainless steel and titanium alloy. The self-tapping 3.5 mm screws are available in lengths from 14- 40 mm in 1 mm increments. The washers have a hole with an inner diameter of 4.2 mm and an outer diameter ranging from 7 to 9 mm in 1 mm increments.
The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acromioclavicular
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)
Mechanical testing was performed on the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device or its components prior to submission for approval. Testing performed included biocompatibility testing (per ISO 10993), screw pull-out testing, mesh burst strength and suture attachment strength. In addition, side-by-side testing was performed against the predicate device in an appropriate cadaveric model.
No clinical testing was performed nor was deemed necessary to demonstrate substantial equivalence.
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 word "SURGICRAFT" in a stylized font. Above the word, there are two curved lines, one above the other, that appear to be part of the logo. The letters of the word are bold and have a textured appearance, giving them a slightly rough or distressed look. The overall impression is that of a brand name or logo for a company, possibly in the medical or surgical field.
510(k) Summarv
| Contact: | Donald W. Guthner
Orgenix, LLC
111 Hill Road
Douglassville, PA 19518
(646) 460-2984 |
|--------------------|----------------------------------------------------------------------------------------------------------|
| Device Trade Name: | LOCKDOWNTM Acromioclavicular (AC) device. |
| Manufacturer: | Surgicraft (Trading Name of Mandaco 569 Limited)
16 The Oaks
Clews Road
Redditch, UK
B98 7ST |
| Classification: | 21 CFR 888.3030, Single/multiple component metallic bone
fixation appliances and accessories |
| Class: | II |
| Product Code: | HTN |
Indications For Use:
The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Device Description:
The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is a combination of two FDAcleared Surgicraft Products, the Surgicraft LOCKDOWN Mesh (K072370) and the Surgicraft LOCKDOWN Screw (K080447). The new product for this indication is designated as the LOCKDOWN™ Acromioclavicular (AC) device and will have a new indication to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
It is not intended that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device be used as the sole means of reconstructing a chronic acromioclavicular joint dislocation.
The Surgicraft LOCKDOWN Mesh device is a woven mesh 11mm wide by 4 to 20 cm in length with loops at both ends. The Surgical Mesh is made from braided Polyethyleneterephthalate (Polyester) fibers (PET).
Manufactured by:
Surgicraft (Trading name of Mandaco 569) / 16 The Oaks / Clews Road / Redditch / Worcestershire / B98 7ST / UK T: +44 1527 512600 / F: +44 1527 512612 / E: info@surgicraft.co.uk / www.surgicraft.co.uk
1
14091207
The Surgicraft LOCKDOWN Screw is manufactured from stainless steel and titanium alloy. The self-tapping 3.5 mm screws are available in lengths from 14- 40 mm in 1 mm increments. The washers have a hole with an inner diameter of 4.2 mm and an outer diameter ranging from 7 to 9 mm in 1 mm increments.
The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is provided sterile.
Predicate Device(s):
The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device was shown to be substantially equivalent to the Arthrex TightRope® Acromioclavicular device (K052776) and has the same indications for use, function and/or materials.
- The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device and the named predicate . device both use braided Polyethyleneterephthalate (Polyester) fibers (PET), stainless steel and titanium materials to fixate acromioclavicular separations.
- Both devices contraindicate the use of the device as the sole means of reconstructing a . chronic acromioclavicular joint dislocation.
- The indications for use statements for both devices are identical. .
Performance Standards:
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act applicable to this device. Side-by-side testing was performed with the named predicate device in appropriate cadaver models and indicated that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is substantially equivalent to predicate device.
Non-Clinical Testing
Mechanical testing was performed on the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device or its components prior to submission for approval. Testing performed included biocompatibility testing (per ISO 10993), screw pull-out testing, mesh burst strength and suture attachment strength. In addition, side-by-side testing was performed against the predicate device in an appropriate cadaveric model.
Clinical Testing
No clinical testing was performed nor was deemed necessary to demonstrate substantial equivalence.
Conclusions
Surgicraft considers the LOCKDOWN™ Acromioclavicular (AC) device to be equivalent to the predicate device listed above. This conclusion is based upon the devices similarities in function, materials and indications for use.
Image /page/1/Picture/17 description: The image shows the word "SURGICRAFT" in a bold, sans-serif font. Above the word, there are three curved lines stacked on top of each other. The lines are slightly offset, creating a sense of movement or flow. The overall design is simple and modern.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted as a staff with two snakes coiled around it and wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Surgicraft, Ltd. % Mr. Donald W. Guthner Orgenix, LLC l 1 l Hill Road Douglassville, Pennsylvania 19518
FEB 1 5 201
Re: K091207
Trade/Device Name: Surgicraft LOCKDOWN™ Acromioclavicular (AC) device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: January 5, 2010 Received: January 6, 2010
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. 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
. . . . . . . . . . . . . . . . . . . . . . . . . . .
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Page 2 - Mr. Donald W. Guthner
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 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/ucm1.15809.html 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,
Sincerely yours,
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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Image /page/4/Picture/0 description: The image shows the word "SURGICRAFT" in a bold, sans-serif font. Above the word, there are two curved lines, resembling a stylized wave or swoosh. The text is the main focus of the image.
Indications for Use
510(k) Number (if known): K091207
Device Name: Surgicraft LOCKDOWN™ Acromioclavicular (AC) device
The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Over-The-Counter Use Prescription Use V AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
for W.M.Mulkern
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091207