(87 days)
Not Found
No
The summary describes a mechanical bone staple and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a staple used for fixation of bone fractures or bone reconstruction, which is a medical device but not inherently a therapeutic device in the same way a drug or therapy device (like a physical therapy machine) would be. It's a surgical implant for structural support, not directly providing therapy.
No
The device description and intended use indicate it is a surgical staple for bone fixation and reconstruction, not for diagnosis.
No
The device description clearly indicates a physical staple ("UNI-CLIP® STAPLE") designed for bone fixation, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of bone fracture or for bone reconstruction" in the hand or foot. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device (a staple) designed for mechanical compression and fixation of bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to physically stabilize bone.
N/A
Intended Use / Indications for Use
- The UNI-CLIP® STAPLE is implanted for fixation of bone fractures or for bone reconstructions.
- The "new" UNI-CLIP® STAPLE is INDICATED FOR USE: M. INDICATIONS I ON OBE fractures or for bone reconstruction, Examples includeng :
- Arthrodesis in hand or foot surgery ●
- Mono or Bi-cortical osteotomies in the foot or hand .
- Fractures management in the foot or hand .
- Distal or proximal metatarsal or metacarpal osteotomies .
- Distal of proximal metadisal of meadarpareatment (such as Scarf, Chevron, etc.) .
- The *new" uni-clip® staple is indicated for fixation of bone fracture or for bone reconstraucion, including:
- Arthrodesis in hand or foot surgery .
- Mono or Bi-cortical osteotomies in the foot or hand ●
- Fracture management in the foot or hand ●
- Distal or proximal metatarsal or metacarpal osteotomies .
- Fixation of osteotomies for Hallux Valgus treatment such as . scarf, chevron, etc.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The UNI-CLIP® STAPLE is designed so that, K. DESCAN TION OF OF OF OF Clanical deformation leads to narrowing of the by widening the "chamond", mosseon can obtain a true compression, adjustable and controlled, with many choices of size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or foot
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)
Torque of divergence and strength of compression of P. SUMMARY OF STODIES. " Torque of arrorgents ALE is the same as for the the Rupture torque of the "heve a resistance to torsion in compliance with the selected standard.
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.
K991482, K993714, K904220, K991962
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 and contact information for a company called "newdeal". The address is listed as NEWDEAL SA, 31 RUE DE LA CONVENTION, PARC D'ACTIVITÉS GARIGLIANO, 38200 VIENNE, FRANCE. The telephone number is (33) 04 74 78 15 15, and the fax number is (33) 04 74 78 15 16. The internet email address is NEWDEALFR@AOL.COM.
AUG 3 0 2001
K 0117/6
SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR IDENTIFICATION: A. NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE
Tél. : (33) 4 74 78 15 15 Fax : (33) 4 74 78 15 16
ESTABLISHMENT REGISTRATION NUMBER: B.
9615741
OFFICIAL CONTACT PERSON C.
Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854 estrin@yourFDAconsultant.com Tel. : (301) 279 -2899 Fax : (301) 294-0126
DATE OF PREPARATION OF THIS SUMMARY: May 31, 2001 D.
UNI-CLIP® STAPLE PROPRIETARY (TRADE) NAME: E.
- Bone fixation staple F. COMMON NAME: True compression, adjustable and controlled.
- CLASSIFICATION NAME AND REFERENCE: ে Staple, Fixation, Bone (21 CFR, Section 888.3040)
SA au capital de 1.000.000 F - Nº Siret 412 111 510 000 19 - NAF 331B - 412 111 510 RCS Vie
000041
1
- PROPOSED REGULATORY CLASS: Class II H.
- 87JDR DEVICE PRODUCT CODE: I.
- OR J. PANEL CODE: PANEL CODE:
DESCRIPTION OF DEVICE: The UNI-CLIP® STAPLE is designed so that, K. DESCAN TION OF OF OF OF Clanical deformation leads to narrowing of the by widening the "chamond", mosseon can obtain a true compression, adjustable and controlled, with many choices of size. - The UNI-CLIP® STAPLE is implanted for fixation of bone INTENDED USE: L. fractures or for bone reconstructions.
- The "new" UNI-CLIP® STAPLE is INDICATIONS FOR USE: M. INDICATIONS I ON OBE fractures or for bone reconstruction, Examples includeng :
- Arthrodesis in hand or foot surgery ●
- Mono or Bi-cortical osteotomies in the foot or hand .
- Fractures management in the foot or hand .
- Distal or proximal metatarsal or metacarpal osteotomies .
- Distal of proximal metadisal of meadarpareatment (such as Scarf, Chevron, etc.) .
- PREDICATE DEVICE: The "new" UNI-CLIP® STAPLE is substantially
Collections of the Comment Coast 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 -N. PREDICATE DEVICE: THE TREW UNICOLICAL (K991482), the Memory Staple( DePuy)
equivalent to the UNI-CLIP® STAPLE (K991482), the Memory Staple(Departic equivalent to the ONF-CDF (Biomedical Ent) (K993714), the EIS Dynamic (K904220), the memograph Stapine) (K991962), the HTO Compression staple Memory Staple (Groupe Leptite) Richards Fixation Staples (Smith and Nephew Richards).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 0.
Both the UNI-CLIP® STAPLE have the same intended of use and all are Both the UNFCEII - STAR DE nave also salonies. All are made from stainless steel.
- SUMMARY OF STUDIES: Torque of divergence and strength of compression of P. SUMMARY OF STODIES. " Torque of arrorgents ALE is the same as for the the Rupture torque of the "heve a resistance to torsion in compliance with the selected standard.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
NewDeal SA c/o Norman F. Estrin, Ph.D. President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K011716 Trade Name: Uni-Clip® Staple Regulation Number: 888.3030 Regulatory Class: II Product Code: JDR Dated: May 30, 2001 Received: June 4, 2001
Dear Dr. Estrin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to vour premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
3
Page 2 - Norman F. Estrin, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your do the same contact the Office of Compliance at additionally 807.10 for m viro diagnestions on the promotion and advertising of your device, (201) 394-4659. Additionally, for questions on are particulars of any and one of any of the regulation entitled, «Misbranding by reference to premarket notification» (21CFR 807.97). Other general entitled, "Missuanding by reicher to premarket nowledged from the Division of Small
information on your responsibilities under the Act may be obtained from (900) (30, 2011) a information on your responsibilities and its toll-free number (800) 638-2041 or
Manufacturers International and Consumer Assistance at its toll-free number in the University Manufacturers International and Sollass "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark n Mellema
Celia 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
4
510(k) Number (if known): K011716
Device Name: Uni-Clip Staple
Indications For Use:
The *new" uni-clip® staple is indicated for fixation of bone fracture or for bone reconstraucion, including:
- Arthrodesis in hand or foot surgery .
- Mono or Bi-cortical osteotomies in the foot or hand ●
- Fracture management in the foot or hand ●
- Distal or proximal metatarsal or metacarpal osteotomies .
- Fixation of osteotomies for Hallux Valgus treatment such as . scarf, chevron, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lo Mark N Mikkelsen
ivision of General, Restorative and Neurological I
510(k) Number
Koll +16
OR
Over-The-Counter Use_No
Prescription Use Yes (Per 21 CFR 801.109)
(Optional Format 1-2-96)