(18 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical plate and screw system for orthopedic surgery and makes no mention of AI or ML technology.
Yes
The device is intended to treat fractures, osteotomies, and non-unions, which are therapeutic interventions for bone problems.
No
The device is described as a plate and screw system intended to treat fractures, osteotomies, and non-unions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "plate and screw system," which are physical hardware components used for orthopedic surgery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that this device is a "plate and screw system" intended to treat fractures and other bone issues. It is a surgical implant used within the body.
- Intended Use: The intended use is to fix bones, not to analyze biological samples.
Therefore, based on the provided information, the Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set is a plate and screw system, intended to treat fractures osteotomies and non-unions of various bones, including but not limited to, the radius, ulna, proximal and distal tibia, pelvis, clavicle, fibula, humerus and scapula particularly in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS, KTT
Device Description
The Swiss Orthopedic Solutions Inc. Small Fragment Locking Set is a plate and screw system. The available plate selection consists of straight, reconstruction, tubular, and various "T" and "L" shapes. The screws with the system are 3.6mm locking screws. The plates in the system can also accept standard spherical 2.7mm, 3.5mm and 4.0mm bone screws and cannulated bone screws. The plate features a hole that is fully threaded, allowing the use of any screw in a variety of positions. The system is available in either stainless steel or titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius, ulna, proximal and distal tibia, pelvis, clavicle, fibula, humerus and scapula
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 plates which are included in this set, are manufactured of from biocompatible materials commonly used in the orthopedic industry. The plates were shown to exhibit strength characteristics comparable to the predicate devices. No new indications have been introduced with these devices. Therefore, the Swiss Orthopedic Solutions Inc. Small Fragment Locking Plate set is considered to be a safe and effective means of fracture fixation.
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.
Synthes (USA) Dynamic Locking Compression (DCL) System, also known as the Locking Compression Plate Set.
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
§ 888.3030 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
K031609
Page 1 of 1
Attachment VI Summary of Safety and Effectiveness Information 510(k) Summary
| Sponsor: | Swiss Orthopedic Solutions Inc.
26 Turnstone Way
Downingtown, PA 19335
Phone: (610) 524-8142
Contact: Bob Bennett |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Plate and Bone Screw |
| Classification Name: | Single/multiple component metallic bone fixation appliance and accessories |
| Device Classification: | Class II, 21 CFR 888.3030 and 888.3040 |
| Name of Device: | Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set |
| Predicate Device: | Synthes (USA) Dynamic Locking Compression (DCL) System, also known as
the Locking Compression Plate Set. |
| Description of Device: | The Swiss Orthopedic Solutions Inc. Small Fragment Locking Set is a plate and
screw system. The available plate selection consists of straight, reconstruction,
tubular, and various "T" and "L" shapes. The screws with the system are 3.6mm
locking screws. The plates in the system can also accept standard spherical
2.7mm, 3.5mm and 4.0mm bone screws and cannulated bone screws. The plate
features a hole that is fully threaded, allowing the use of any screw in a variety of
positions. The system is available in either stainless steel or titanium. |
| Indications: | The Swiss Orthopedic Solutions Inc. Small Fragment Locking Plate Set is a plate
and screw system, intended to treat fractures osteotomies and non-unions of
various bones, including but not limited to, the radius, ulna, proximal and distal
tibia, pelvis, clavicle, fibula, humerus and scapula particularly in osteopenic
bone. |
| Substantial
Equivalence: | The Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set is
considered substantially equivalent to the Synthes (USA) Dynamic Compression
Locking (DCL) System, also known as the Locking Compression Plate Set. |
| Safety and
Effectiveness: | The plates which are included in this set, are manufactured of from
biocompatible materials commonly used in the orthopedic industry. The plates
were shown to exhibit strength characteristics comparable to the predicate
devices. No new indications have been introduced with these devices.
Therefore, the Swiss Orthopedic Solutions Inc. Small Fragment Locking Plate set
is considered to be a safe and effective means of fracture fixation. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol resembling three stylized human profiles or a bird in flight, rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 9 2003
Mr. Bob Bennett Swiss Orthopedic Solutions, Inc. 26 Turnstone Way Downingtown, PA 19335
Re: K031609
Trade/Device Name: Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, KTT Dated: May 20, 2003 Received: May 27, 2003
Dear Mr Bennett:
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.
2
Page 2 - Mr. Bob Bennett
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
Colia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page: 1 of 1
510(k) Number (if known): K031609
Device Name: Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set
Indications for Use:
The Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set is a plate and screw system, intended to treat fractures osteotomies and non-unions of various bones, including but not limited to, the radius, ulna, proximal and distal tibia, pelvis, clavicle, fibula, humerus and scapula particularly in osteopenic bone.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
Miriam C. Provost
(Division Sign-Off) Division of Comeral, Restorative and Neurological Devices
510(k) Number K 031609
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