(112 days)
No
The device description and intended use clearly define a mechanical plating system for bone fixation. There is no mention of any software, image processing, or AI/ML terms. The performance studies are based on mechanical testing, not algorithmic performance.
Yes.
The device is a plating system intended for fixation in various foot arthrodeses and osteotomies, which are medical procedures designed to treat conditions and improve patient health.
No
Explanation: The CLAW® II Polyaxial Compression Plating System is used for fixation in midfoot and hindfoot arthrodeses or osteotomies, and other similar surgical procedures. It is a system of plates and screws intended for the physical stabilization of bones, not for diagnosing conditions.
No
The device description explicitly states it consists of "plates and screws of various anatomic configurations and lengths" made from "implant grade stainless steel." This indicates a physical hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for fixing bones in the foot and ankle. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details plates and screws made of stainless steel, designed for surgical implantation. This aligns with a surgical device, not a device used to examine specimens from the body.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (blood, tissue, urine, etc.), which is a core characteristic of IVDs.
- Focus on mechanical performance: The performance studies described focus on mechanical testing and equivalence to predicate devices, which is typical for surgical implants.
In summary, the CLAW® II Polyaxial Compression Plating System is a surgical implant intended for bone fixation, not for diagnosing diseases or conditions through the examination of in vitro specimens.
N/A
Intended Use / Indications for Use
The CLAW® II Polyaxial Compression Plating System is intended to be used for fixation such as:
- · Midfoot and hindfoot arthrodeses or osteotomies
- · Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocubid, Lapidus)
- · Intercuneiform arthrodeses
- · Naviculocuneiform arthrodeses
- · Talonavicular arthrodeses
- · Calcaneocuboid arthrodeses
- · Lisfranc arthrodeses
- · Mono- or bi-cortical osteotomies in the forefoot, midfoot and hindfoot
- · Fixation of osteotomies for hallux valgus treatment (Scarf and Chevron)
- · Akin osteotomies
- · First metatarsophalangeal arthrodeses
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The CLAW® II Polyaxial Compression Plating System consists of plates and screws of various anatomic configurations and lengths. All plates and screws are manufactured from implant grade stainless steel. The plates accept 2.7mm and 3.5mm ORTHOLOCTM 3DSi locking screws.
The ORTHOLOC™ 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.
The design features of the CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screws are substantially equivalent to the design features of the predicate devices identified in this premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Midfoot, hindfoot, tarsometatarsal, intercuneiform, naviculocuneiform, talonavicular, calcaneocuboid, Lisfranc, forefoot, first metatarsophalangeal.
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)
Substantial equivalence is shown through worst-case plate analysis, plate mechanical testing, polyaxial performance testing, and descriptive information. The results of the test show that the subject CLAW® II Polyaxial Compression Plating System and ORTHOLOCTM 3DSi Locking Screws can be expected to perform at least as well as the legally marketed predicate identified in this 510(k) submission.
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.
K093914, K091614, K101240, K083843, K073624, K100618
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
JAN 3 1 2012
Image /page/0/Picture/1 description: The image shows the text "K113014 PAGE 1 OF 3 WRIGHT." in a bold, sans-serif font. The text "K113014" is at the top of the image, followed by "PAGE 1 OF 3" below it. The word "WRIGHT" is the largest text in the image and is located at the bottom. There is a decorative graphic below the word "WRIGHT."
The Leader in Foot & Ankle Surgery.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the CLAW® II Polyaxial Compression Plating System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd
Arlington, TN 38002 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 7, 2011 |
| Contact Person: | Peggy S. Rivers
Regulatory Affairs Specialist
(901) 867-4759 |
| (a)(2). Proprietary Name: | CLAW® II Polyaxial Compression Plating
System
ORTHOLOC™ 3DSi Locking Screw |
| Common Name: | Plate System and Locking Screws |
| Device Classification Regulation: | 21 CFR 888.3030—Class II |
| Device Product Code & Panel: | HRS: Plate, Fixation Bone
87 orthopedics |
| (a)(3). Predicate Device: | K102352—EVOLVE® EPS ORTHOLOC™
System
K051908—CHARLOTTE® CLAW® Plating
System
K080295—CHARLOTTE® CLAW® 3.5 Plating
System |
1
K093914- NEWDEAL® COMPRESSION PLATES K091614-OSTEOMED FOOT PLATING SYSTEM K101240-DEPUY ALPS SMALL BONE LOCKED PLATING SYSTEM K083843—LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM K073624-MODULAR FOOT SYSTEM K100618-MAXLOCK EXTREME® EXTREMITY PLATING SYSTEM
(a)(4). Device Description
The CLAW® II Polyaxial Compression Plating System consists of plates and screws of various anatomic configurations and lengths. All plates and screws are manufactured from implant grade stainless steel. The plates accept 2.7mm and 3.5mm ORTHOLOCTM 3DSi locking screws.
The ORTHOLOC™ 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.
The design features of the CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screws are substantially equivalent to the design features of the predicate devices identified in this premarket notification.
(a)(5). Intended Use
Wright's CLAW® II Polyaxial Compression Plating System is intended to be used for fixation such as:
- · Midfoot and hindfoot arthrodeses or osteotomies
- · Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocubid. Lapidus)
- · Intercuneiform arthrodeses
- · Naviculocuneiform arthrodeses
- · Talonavicular arthrodeses
- · Calcaneocuboid arthrodeses
- · Lisfranc arthrodeses
- · Mono- or bi-cortical osteotomies in the forefoot, midfoot and hindfoot
- · Fixation of osteotomies for hallux valgus treatment (Scarf and Chevron)
- · Akin osteotomies
- · First metatarsophalangeal arthrodeses
2
(a)(6). Technological Characteristics Comparison
The technological characteristics of the CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screws are substantially equivalent to technological characteristics of the predicates identified in this 510(k) submission.
The subject designs and indications are substantially equivalent to the predicates identified in this 510(k) submission. The subject screws and locking feature are substantially equivalent to the predicates identified in this premarket submission.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence is shown through worst-case plate analysis, plate mechanical testing, polyaxial performance testing, and descriptive information. The results of the test show that the subject CLAW® II Polyaxial Compression Plating System and ORTHOLOCTM 3DSi Locking Screws can be expected to perform at least as well as the legally marketed predicate identified in this 510(k) submission.
The safety and effectiveness of the CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screws are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
Substantial equivalence is shown through worst-case plate analysis, plate mechanical testing, polyaxial performance testing, and descriptive information. The subject CLAW® Polyaxial Compression Plating System designs are similar to the previous = CHARLOTTE® CLAW® 3.5 designs in basic plate form, size and hole placement. The subject designs and indications are substantially equivalent to the predicates identified in this 510(k) submission. The subject CLAW® II Polyaxial Compression Plating System locking holes contain the ORTHOLOC™ design feature which was 501(k) cleared with the ORTHOLOC™ EVOLVE® EPS System, 510(k) K102352. No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 3 1 2012
Wright Medical Technology, Inc. % Ms. Peggy S. Rivers 5677 Airline Road Arlington, TN 38002
Re: K113014
Trade/Device Name: CLAW® II Polyaxial Compression Plating System ORTHOLOCTM 3DSi Locking Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories
Regulatory Class: II Product Code: HRS, HWC Dated: January 11, 2012 Received: January 13, 2012
Dear Ms. Rivers:
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
4
Page 2 - Ms. Peggy S. Rivers, Regulatory Affairs Specialist II
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health ·
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screw
Indications For Use:
The CLAW® II Polyaxial Compression Plating System is intended to be used for fixation such as:
- · Midfoot and hindfoot arthrodeses or osteotomies
- · Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocubid, Lapidus)
- · Intercuneiform arthrodeses
- · Naviculocuneiform arthrodeses
- · Talonavicular arthrodeses
- · Calcaneocuboid arthrodeses
- · Lisfranc arthrodeses
- · Mono- or bi-cortical osteotomies in the forefoot, midfoot and hindfoot
- · Fixation of osteotomies for hallux valgus treatment (Scarf and Chevron)
- · Akin osteotomies
- · First metatarsophalangeal arthrodeses
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113014
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