(58 days)
Not Found
No
The summary describes a mechanical fixation system (plates and screws) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The performance studies are mechanical tests.
No.
The device is indicated for fixation of fractures and osteotomies, and reconstruction of small bones, which are structural and mechanical functions, not therapeutic.
No
The device is a plating and screw system for fixation of fractures and osteotomies, which are treatment procedures, not diagnostic ones.
No
The device description clearly states it is a "lower extremity fixation system" consisting of "ParaLock Plates" and "TUFFNEK™ screws," which are physical implants used for bone stabilization and fixation. This indicates a hardware-based medical device, not a software-only one.
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 for the "stabilization and fixation of fractures or osteotomies" and other surgical procedures involving bone. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details bone plates and screws, which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The ParaLock Bone Plates and TUFFNEK Bone Screws of the ParaLock Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi- fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.
In addition, the TUFFNEK non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The ParaLock Plating System and TUFFNEK screws are lower extremity fixation systems. ParaLock Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. TUFFNEK screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the TUFFNEK screws when the latter are used for fixation without the plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
toes, feet and ankles including the distal tibia, talus, and calcaneus.
Indicated Patient Age Range
The system can be used in both adult and pediatric patients.
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 of the worst case ParaLock Plates included static and dynamic bending performed according to ASTM F382. Mechanical testing of the worst case TUFFNEK screws included torsion, insertion/removal and pullout performed according to ASTM F543. The mechanical test results and theoretical comparisons demonstrated that the mechanical performance of the ParaLock Plating System and TUFFNEK screws is substantially equivalent to the predicate devices.
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.
K011118, K022324, K022325, K120359, K121425, K121651, K043583, K050819, K924018, K032187, K040907, K052614, K103705, K111253, K063875, K101962, K120157, K121437, K091614
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.
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K140397 page 1 of 2
510(k) Summary
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| Date: | 14 February 2014 |
|---|---|
| Sponsor: | Paragon 28, Inc. |
| 4B Inverness Ct. E., STE 280 | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888 | |
| Facsimile: (888) 728-1220 | |
| Contact Person: | Frank S. Bono, Chief Technology Officer |
| Trade Names: | ParaLock Plating System ™ |
| Device Classification | Class II |
| Regulations, Product | |
| Codes, Classification | |
| & Common Names: | 888.3030, HRS, Single/multiple component metallic bone fixation appliances and accessories, bone plate system |
| 888.3040, HWC, Smooth or threaded metallic bone fixation fastener, bone screw | |
| 888.3030, HTN, Single/multiple component metallic bone fixation appliances and accessories, washer | |
| Device Description: | The ParaLock Plating System ™ and TUFFNEK ™ screws are lower extremity fixation systems. ParaLock Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. TUFFNEK ™ screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the TUFFNEK ™ screws when the latter are used for fixation without the plates. |
| Intended Use: | The ParaLock Bone Plates and TUFFNEK ™ Bone Screws of the ParaLock Plating System ™ are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi- fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients. In addition, the TUFFNEK ™ non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. |
| Materials: | The ParaLock and TUFFNEK ™ implants are manufactured from medical grade titanium (per ASTM F67) and titanium alloy (per ASTM F136). |
| Predicate Devices: | • The Normed Extremity Titanium Hand and Small Fragment System, the Normed Titanium Calcaneus Plating with Locking Screw System and the Normed Titanium Osteotomy Plating System (Osteomedics Inc - K011118, K022324 and K022325, respectively) |
| • The Wright Medical ORTHOLOC ™ 3Di Hallux System, The Wright Medical ORTHOLOC ™ 3Di Ankle Fusion Plating System and The Wright Medical ORTHOLOC ™ 3Di Midfoot/Flatfoot System (Wright Medical Technology, Inc. - K120359, K121425 and K121651, respectively) | |
| • CHARLOTTE ™ Snap-Off Screw (Wright Medical Technology, Inc. K043583, K050819) | |
| • M3-X Extremity Fixation (OsteoMed Corp., K924018) | |
| • The Arthrex Titanium Opening Wedge Osteotomy System, the Arthrex Small Fragment Plates and Screws, Low Profile Plate and Screw System, the Arthrex Low Profile Screws and The Arthrex Distal Extremity Plate System (Arthrex, Inc. - K032187, K040907, K052614, K103705 and K111253, respectively) |
APR 1 7 2014
·
:
1
| | • The Stryker® Foot Plating System (Howmedica Osteonics - K063875)
• The Mini MaxLock Extreme® Plating System (OrthoHelix Surgical Designs
Inc. - K101962, K120157 & K121437)
• OsteoMed Foot Plating System ("FPS" OsteoMed LP - K091614) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Mechanical testing of the worst case ParaLock Plates included static and
dynamic bending performed according to ASTM F382. Mechanical testing of
the worst case TUFFNEK™ screws included torsion, insertion/removal and
pullout performed according to ASTM F543. The mechanical test results and
theoretical comparisons demonstrated that the mechanical performance of the
ParaLock Plating System™ and TUFFNEK™ screws is substantially
equivalent to the predicate devices. |
| Technological
Characteristics: | The ParaLock Plating System™ and TUFFNEK™ screws possess the same
technological characteristics as one or more of the predicate devices. These
include: |
| | • performance (as described above),
• basic design (screws and plates in various shapes),
• material (titanium and/or titanium alloys) and
• sizes (dimensions are comparable to those offered by the predicate
systems). |
| | Therefore the fundamental scientific technology of the ParaLock Plating
System™ is the same as previously cleared devices. |
| Conclusion: | The ParaLock Plating System™ and TUFFNEK™ screws possess the same
intended use and technological characteristics as the predicate devices.
Therefore the ParaLock Plating System™ and TUFFNEK™ screws are
substantially equivalent for its intended use. |
and the contraction of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of
..
.
2
Image /page/2/Picture/0 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 that resembles an eagle or bird-like figure with three stylized wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2014
Paragon 28, Inc. % Ms. Karen E. Warden, Ph.D. Representative/Consultant BackRoads Consulting, Inc. PO Box 566 Chesterland, Ohio 44026-0566
Re: K140397
Trade/Device Name: ParaLock 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, HTN Dated: March 3, 2014 Received: March 4, 2014
Dear Dr. Warden:
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 comply with all the Act's requirements, including, but not limited to: registration and listing
3
Page 2 - Dr. Karen E. Warden
(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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/dcfault.htm.
Sincerely vours.
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K140397 page 1 of 1
Indications for Use Statement
K140397 510(k) Number:
Device Name: ParaLock Plating System™
Indications for Use:
The ParaLock Bone Plates and TUFFNEK™ Bone Screws of the ParaLock Plating System™ are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.
In addition, the TUFFNEK™ non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use _ X OR (Per 21 CFR 801.109)
(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