(199 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) and the performance studies are focused on mechanical properties. There is no mention of AI/ML terms, image processing, or data sets for training/testing.
No
The device is an implantable system for fracture fixation, which is a structural and mechanical support, not a therapeutic agent or device that directly treats a disease or condition.
No
Explanation: The device is an implant system (plates and screws) used for fixation of clavicle fractures, mal-unions, non-unions, and osteotomies. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of physical plates and screws made of titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates and screws made of titanium, designed for surgical implantation.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device is implanted inside the body.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The implants of the Newclip Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Clavicle Locking Plating System consists of a range of plates and screws for clavicle surgery. Each device is manufactured from titanium and color anodized. The Clavicle Locking Plating System will be provided non-sterile for steam sterilization by health care professional's prior use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle
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 following tests were conducted:
- Comparative bending test on Clavicle plates according ASTM F 382-99 . Annex Al.
- Comparative fatigue test on Lateral Clavicle plates according ASTM F 382 -. 99 - Annex A2.
- Comparative torsional test on each type of screws according ASTM F543-07 . Annex A1.
- Comparative mechanical pullout test on each type of screws according to . ASTM F543-07 Annex A3.
No clinical studies were performed.
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.
K012655, K061352, K073186, K050852
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
Image /page/0/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is in large, bold, black letters. Below that, the word "TECHNICS" is in smaller, gray letters. Above the word "NEWCLIP" is a curved line that resembles a clip.
K100944
OCT 22 2010
510 (k) Summary for the Newclip Clavicle Locking Plating System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Newclip Clavicle Locking Plating System.
Summary preparation date: September 15, 2010
1. Submitter:
Contact Person:
| NEWCLIP TECHNICS
Z.A du Pâtis
Rue de la Fontaine Grillée
F-44 690 La Haye-Fouassière - France
Telephone: (33) 2 28 21 37 12 | J.D. Webb
The OrthoMedix Group, Inc.
1001 Oakwood Blvd
Round Rock, TX 78681
Telephone: 512-388-0199 |
| ----------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------- |
|---|
- Newclip Clavicle Locking Plating 2. Trade name:
System
Medial Clavicle Plates and screws Lateral Clavicle Plates and screws
Common Name:
Classification Name:
Plate, Fixation, Bone (21 CFR part. 888.3030)
Screw, Fixation, Bone (21 CFR part. 888.3040)
Predicate or legally marketed devices which are substantially equivalent: 3.
- The Locking Clavicle Plates System of the Congruent Bone Plate System of . Acumed, Inc. (K012655),
- The Clavicle Locking Plates of the Peri-Loc Periarticular Locked Plating . System for the Upper Extremity of Smith & Nephew; Inc. (K061352),
- The 3.5mm LCP Clavicle Plate System of Synthes (K073186), .
- The Claviculaplate with Angular Stability System of I.T.S. Implantat-Technologie-Systeme GmbH (K050852).
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Image /page/1/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is written in large, bold, black letters. Below "NEWCLIP" is the word "TECHNICS" written in smaller, gray letters. Above the word "NEWCLIP" is a black semi-circle.
| 4. Description of the device: | The Clavicle Locking Plating System consists of a range of plates and screws for clavicle surgery. Each device is manufactured from titanium and color anodized. The Clavicle Locking Plating System will be provided non-sterile for steam sterilization by health care professional's prior use. |
|---|---|
| Materials: | Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136-02a and/or ISO 5832-3). |
| Function: | The implants of the Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle. |
5. Substantial equivalence claimed to predicate devices:
The Clavicle Locking Plating System is substantially equivalent to the Locking Clavicle Plates System of the Congruent Bone Plate System of Acumed, Inc. (K012655), the Clavicle Locking Plates of the Peri-Loc Periarticular Locked Plating System for the Upper Extremity of Smith & Nephew; Inc. (K061352), the 3.5mm LCP Clavicle Plate System of Synthes (K073186) and the Claviculaplate with Angular Stability System of I.T.S. Implantat-Technologie-Systeme GmbH (K050852) in terms of intended use, design, materials used, mechanical safety and performance.
2
Image /page/2/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is in large, bold, black letters. Below that, in smaller letters, is the word "TECHNICS". Above and to the right of the word "NEWCLIP" is a curved line that resembles a sunrise.
The table below compares the features and characteristics of the Newclip Clavicle Locking Plating System to these predicate devices:
| Sponsor | NEWCLIP
TECHNICS
S.A.S. | I.T.S. | ACUMED, INC. | SYNTHES | SMITH &
NEPHEW, INC. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Newclip
Clavicle
Locking
Plating System | Claviculaplate
with Angular
Stability
System | Congruent
Bone
Plate System
Clavicle Locking
Plates | 3.5 mm LCP
Clavicle Plate
System | Peri-Loc
Periarticular
Locked Plating
System
Clavicle Locking
Plates |
| 510(K) Number | K100994 | K050852 | K012655 | K073186 | K061352 |
| Regulatory
Class | II | II | II | II | II |
| Device
Classification
Name | Plate, Fixation,
Bone | Plate, Fixation,
Bone | Plate, Fixation,
Bone | Plate, Fixation,
Bone | Plate, Fixation,
Bone |
| Product Code | HRS | HRS | HRS | HRS | HRS |
| Panel Code | 888.3030 | 888.3030 | 888.3030 | 888.3030 | 888.3030 |
| Intended use | | | | | |
| Indications for
Use | Fixation
of
fractures,
mal-
unions,
non-
unions,
and
osteotomies
of
the clavicle. | Metaphysial and
diaphyseal
fracture fixation
of
acute
fractures,
malunions,
and
non-unions
of
the clavicle.
Corrective
osteotomy
and
open and closed
fractures. | Fixation
for
fractures,
fusions,
or
osteotomies
for
the clavicle,
humerus,
radius,
ulna,
metacarpal,
metatarsal,
malleolus, tibia,
and fibula. | Fixation
of
fractures,
mal-
unions,
non-
unions,
and
osteotomies
of
the clavicle. | Fixation
of
pelvic,
small
and long
bone
fractures,
including
those
of the
tibia,
fibula, femur,
and pelvic,
osteotomies of
acetabulum,
metacarpal,
humerus, ulna,
radius,
calcaneus and
clavicle. |
| Plates design | | | | | |
| o Design | Anatomic
contour
Pre-contoured | Anatomic
contour
Pre-contoured | Anatomic
contour
Pre-contoured | Anatomic
contour
Pre-contoured | Anatomic
contour
Pre-contoured |
| Devices | | | | | |
| o Midshaft
Clavicle
plates | Yes | Yes | Yes | Yes | Yes |
| o Distal Clavicle
plates | Yes | Yes | Yes | Yes | Yes |
| o Fixation
system | Combination
of
locking and non-
locking screws | Combination
of
locking and non-
locking screws | Combination
of
locking and non-
locking screws | Combination
of
locking and non-
locking screws | Combination
of
locking and non-
locking screws |
| Materials | | | | | |
| o Plates | Titanium | Titanium | Titanium | Titanium
or stainless
steel | Stainless steel |
| o Screws | Titanium | Titanium | Titanium | Titanium
or stainless
steel | Stainless steel |
| o Anodization | Yes | No | Yes | Yes | No |
3
Image /page/3/Picture/0 description: The image shows the logo for Newclip Technics. The word "NEWCLIP" is in large, bold, black letters. Below that, in smaller letters, is the word "TECHNICS". Above the word "NEWCLIP" is a curved line that resembles a clip.
6. Intended use:
The implants of the Newclip Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative bending test on Clavicle plates according ASTM F 382-99 . Annex Al.
- Comparative fatigue test on Lateral Clavicle plates according ASTM F 382 -. 99 - Annex A2.
- Comparative torsional test on each type of screws according ASTM F543-07 . Annex A1.
- Comparative mechanical pullout test on each type of screws according to . ASTM F543-07 Annex A3.
8. Non-clinical Test Summary:
No clinical studies were performed.
9. Conclusions Nonclinical and Clinical:
The Newclip Clavicle Locking Plating System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Newclip Technics % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
0(T 2 2 2010
Re: K100944
Trade/Device Name: Clavicle Locking Plate 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 Dated: September 29, 2010 Received: October 4, 2010
Dear Mr. Webb:
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, 7 rug and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA). 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Mr. J.D. Webb
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Barbara Buend
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosúre
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Image /page/6/Picture/0 description: The image shows the logo for NEWCLIP TECHNICS. The word "NEWCLIP" is in large, bold, black letters. Below "NEWCLIP" is the word "TECHNICS" in smaller, lighter letters. Above the word "NEWCLIP" is a curved line that resembles a sunrise.
K100944
OCT 22 2010
INDICATIONS FOR USE
510(k) Number (if known): K1009944
Device Name: Clavicle Locking Plating System
Indications for Use:
The implants of the Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.
Prescription Use AND/OR Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
-Page 1 of
Seneta for mxn
(Division Sign Off Division of Surgical, Inthopedic, and Restorative Devices
510(k) Number K100944