(21 days)
Not Found
No
The device description focuses solely on the physical components (plates, screws, instrumentation) and their materials and sizes. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is intended to "draw two or more aligned small bone fragments together to facilitate healing" and is indicated for "stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones," indicating a therapeutic purpose.
No
The device is a plating system used for surgical fixation of bone fractures and fusions, not for diagnosing medical conditions.
No
The device description clearly outlines a system composed of physical plates, screws, and associated instrumentation made from titanium. This is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the stabilization and fixation of bone fragments in the feet, ankles, and toes. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a plating system consisting of metal plates and screws made from titanium. These are implants designed to be surgically inserted into the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The Ortho Solutions UltOS Plating System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Ortho Solutions UltOS Plating System fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing.
The Ortho Solutions UltOS Plating System is Indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the feet, ankles, and toes skeleton.
This implant should only be used with the Ortho Solutions UltOS Plating System. Combination with other implants or instrumentation is not permissible.
The Ortho Solutions UltOS Plating System is not intended for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, KTT
Device Description
The Ortho Solutions UltOS Plating System is designed to address a variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of Twelve(12) Plate Types that accept both a smaller 2.7mm and larger 3.5mm Locking/ Non-locking Screw ( in various lengths of 8mm thru 50mm) with all screw heads of uniform size to fit any plate type. The UltOS System 'Twelve(12) Plate Types' consist of the following:
1). A Arthrodesis Wedge Plate (AWP) in 5 sizes of 0, 2, 4, 6 & 8mm. plate wedge widths,
2). A General Fusion Straight Plate (GFS) in 2 sizes of a 2 & 4 screw hole plate.
3). A General Fusion "T" Plate (GFT) in 3 sizes of a 2, 4 & 6 screw hole plate.
4). A Metatarsophalangeal Plate (MTP) in 3 sizes, Left & Right, of a Small, Medium & Large plate size,
5). A Opening Wedge Locking Plate (OWL) in 6 sizes of 0, 3, 4, 5, 6 & 7mm plate wedge widths,
6). A Opening Wedge Plate (OWP) in 6 sizes of a 0, 2.5, 3, 4, 5 & 7mm plate wedge widths.
7). A Calcaneal Step Plate (CSP) in 3 sizes of 8, 10 & 12mm plate step heights.
8). A General Fusion "X" Plate (GFX) in 4 sizes of a Extra Small, Small. Medium & Large plate size,
9). A Lapidus Plate (LAP) in 4 sizes, Left & Right, of a 0, 2, 4 & 6mm plate offset heights,
10). A Rearfoot Reconstruction Plate (RRP) in 3 sizes of a 6, 8 & 14 screw hole plate.
11). A Tarsal Fusion Plate (TFP) in 3 sizes of a 12, 14 & 16mm plate length, and
12). A Universal Locking Plate (ULP) in 5 sizes of a 12, 16, 20, 24 & 30mm plate length.
Screw diameters of 2.7mm and 3.5mm with either Locking or Non-Locking features and Cannulated 3.5mm self tapping screws in various lengths are also included in the UltOS Plating System.
Associated instrumentation such as compression and distraction pliers, disposable drills & wires/guide wires, drill guides, T8 torx screwdrivers and ancillary instrumentation is available. All plates and screws are manufactured from Alloyed Titanium Ti-6Al-4V to ASTM F136. All plates, screws, drills and K-wires are offered both 'Sterile' and 'Non-Sterile' to the customer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
feet, ankles, and toes skeleton.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical setting.
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 Ortho Solutions UltOS Plating System is shown to be safe and effective as 'sterile' and 'non-sterile' for single-use in a surgical setting.
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.
K111678, K061808, K100359, K100776
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
Ortho Solutions, Limited - 510(k) Summary:
510(k) Summary of Safety and Effectiveness
JUL 2 3 2014
SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary
| NAME OF FIRM: | Ortho Solutions Limited
West Station Business Park
Spital Road
Maldon
ESSEX, CM9 6FF
United Kingdom
www.orthosolutions.com |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372
Tel. No. 952-492-5858
e-mail: allippincott@msn.com |
| DATE: | June 20, 2014 |
| TRADE NAME: | Ortho Solutions – UltOS Plating System |
| COMMON NAME: | Foot Bone Plate System |
| CLASSIFICATION: | Smooth or threaded metallic bone fixation fastener
(per 21CFR888.3040) – Screw, Fixation, Bone |
Single/multiple component metallic bone fixation appliance and accessories (per 21CFR888.3030) - Plate, Fixation, Bone
| DEVICE PRODUCT CODE: | HRS | |
|---|---|---|
| SUBSEQUENT PRODUCT CODE: | HWC, KTT | |
| SUBSTANTIALLY | ||
| EQUIVALENT DEVICES | Ortho Solutions - FPS System (K111678) | |
| Wright Medical- DARCO MFS & MRS Systems (K061808, K100359) | ||
| Synthes - Variable Angle ICP Forefoot/Midfoot System (K100776) |
The Ortho Solutions UltOS Plating System is designed to address a DEVICE DESCRIPTION: variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of Twelve(12) Plate Types that accept both a smaller 2.7mm and larger 3.5mm Locking/ Non-locking Screw ( in various lengths of 8mm thru 50mm) with all screw heads of uniform size to fit any plate type. The UltOS System 'Twelve(12) Plate Types' consist of the following:
Ortho Solutions UltOS Plating System
Page 1 of 3 Section XII
1
Ortho Solutions, Limited - 510(k) Summary: DEVICE DESCRIPTION CONTINUED:
1). A Arthrodesis Wedge Plate (AWP) in 5 sizes of 0, 2, 4, 6 & 8mm. plate wedge widths,
2). A General Fusion Straight Plate (GFS) in 2 sizes of a 2 & 4 screw hole plate.
3). A General Fusion "T" Plate (GFT) in 3 sizes of a 2, 4 & 6 screw hole plate.
4). A Metatarsophalangeal Plate (MTP) in 3 sizes, Left & Right, of a Small, Medium & Large plate size,
5). A Opening Wedge Locking Plate (OWL) in 6 sizes of 0, 3, 4, 5, 6 & 7mm plate wedge widths,
6). A Opening Wedge Plate (OWP) in 6 sizes of a 0, 2.5, 3, 4, 5 & 7mm plate wedge widths.
7). A Calcaneal Step Plate (CSP) in 3 sizes of 8, 10 & 12mm plate step heights.
8). A General Fusion "X" Plate (GFX) in 4 sizes of a Extra Small, Small. Medium & Large plate size,
9). A Lapidus Plate (LAP) in 4 sizes, Left & Right, of a 0, 2, 4 & 6mm plate offset heights,
10). A Rearfoot Reconstruction Plate (RRP) in 3 sizes of a 6, 8 & 14 screw hole plate.
11). A Tarsal Fusion Plate (TFP) in 3 sizes of a 12, 14 & 16mm plate length, and
12). A Universal Locking Plate (ULP) in 5 sizes of a 12, 16, 20, 24 & 30mm plate length.
Screw diameters of 2.7mm and 3.5mm with either Locking or Non-Locking features and Cannulated 3.5mm self tapping screws in various lengths are also included in the UltOS Plating System.
Associated instrumentation such as compression and distraction pliers, disposable drills & wires/guide wires, drill guides, T8 torx screwdrivers and ancillary instrumentation is available. All plates and screws are manufactured from Alloyed Titanium Ti-6Al-4V to ASTM F136. All plates, screws, drills and K-wires are offered both 'Sterile' and 'Non-Sterile' to the customer.
INTENDED USE:
The intended use of the Ortho Solutions UltOS Plating System fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing.
The Ortho Solutions UltOS Plating System is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the feet, ankles, and toes skeleton.
This implant should only be used with the Ortho Solutions UltOS Plating System. Combination with other implants or instrumentation is not permissible.
The Ortho Solutions UltOS Plating System is not intended for spinal use.
Ortho Solutions UltOS Plating System
Page 2 of 3 Section XII
2
Ortho Solutions, Limited - 510(k) Summary:
The Ortho Solutions UltOS Plating System is substantially equivalent EQUIVALENCE: to predicate systems from many orthopedic companies (as listed). No nonclinical testing was used in the determination of substantial equivalence.
The Ortho Solutions UltOS Plating System is similar in Material, SUMMARY OF TECH-Geometry Design/Markings, and Indications to many predicate systems NOLOGICAL CHAR-ACTERISTICS currently sold in the U.S. market.
SUMMARY OF SAFETY AND EFFECTIVENESS:
The Ortho Solutions UltOS Plating System is shown to be safe and effective as 'sterile' and 'non-sterile' for single-use in a surgical setting.
Ortho Solutions UltOS Plating System
Page 3 of 3 Section XII
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Unmoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2014
Ortho Solutions, Limited % Mr. Al Lippincott Engineering Consulting Scrvices. Inc. U.S. Agent and Official Correspondent to Ortho Solutions, Limited 3150 E. 200m St. Prior Lake, Minnesota 55372
Re: K141784
Trade/Device Name: Ortho Solutions UltOS Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, KTT Dated: June 20, 2014 Received: July 2, 2014
Dear Mr. Lippincott:
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 10 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. Iabeling, and prohibitions against misbranding and adulteration. Please note: CDRII 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
4
Page 2 -Mr. Al Lippincott
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.hum.
Sincerely yours,
Lori A. Wiqqins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K141784 510(k) NUMBER:
DEVICE NAME: Ortho Solutions UltOS Plating System
INDICATIONS FOR USE:
The intended use of the Ortho Solutions UltOS Plating System fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing.
The Ortho Solutions UltOS Plating System is Indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the feet, ankles, and toes skeleton.
This implant should only be used with the Ortho Solutions UltOS Plating System. Combination with other implants or instrumentation is not permissible.
The Ortho Solutions UltOS Plating System is not intended for spinal use.
Over-The-Counter-Use Prescription Use _xx______xx_____xx_____xxx____xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx AND/OR (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D) (Please Do Not WRITE BELOW THIS LINE -- Continue on ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
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