(87 days)
Not Found
Not Found
No
The description focuses on the mechanical properties and intended use of bone screws, with no mention of AI or ML.
Yes.
Explanation: The device is used for "fracture fixation," which is a medical treatment to stabilize fractured bones, thereby directly treating a medical condition.
No
Explanation: The device is described as a "Cannulated Screw System" used for "fracture fixation" and other surgical procedures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of physical components like cannulated screws and washers, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Cannulated Screw System is a surgical implant used for fixing bone fractures and performing osteotomies and arthrodesis. It is a physical device inserted into the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens.
Therefore, based on the provided information, the Cannulated Screw System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:
-
- Fractures of the tarsals and metatarsals;
-
- Metatarsal and phalangeal osteotomies;
-
- Fractures of the carpals and metacarpals;
-
- Carpal and metacarpal arthrodesis;
-
- Small fragments of the hand and wrist;
-
- Ligament fixation as appropriate;
-
- Sacroiliac joint disruptions;
-
- Fractures of the distal femur and proximal tibia;
-
- Intracapsular fractures of the hip;
-
- Ankle arthrodesis; and
-
- Pelvis and acetabulum fractures;
This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.
Product codes (comma separated list FDA assigned to the subject device)
HTN, HWC
Device Description
The Cannulated Screw System by Pioneer consists of cannulated screws of varying diameters, lengths and thread configurations to accommodate variations in surgical technique and severity level of fracture. The system includes correspondingly sized washers, the use of which is optional. The cannulated screws are self-cutting and self-tapping in appropriate bone stock, which maximizes OR efficiency. The threads are tapping in approphato bone otew removal and decreasing the chance of breakage. reverse batting, faoilitating of engle use and will be offered both sterile and nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long and small bone, tarsals, metatarsals, phalangeal, carpals, metacarpals, hand, wrist, sacroiliac joint, distal femur, proximal tibia, hip, ankle, pelvis, acetabulum. Not indicated for use in the spine.
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)
Based on the screw material equivalence in the proposed system an at least equivalent comparison has been logically derived from the information available.
The Cannulated Screw System by Pioneer is predicated on the use Zimmer Magna-FX and Synthes Cannulated screws. The Cannulated Screw system by Pioneer will be evaluated and compared to the predicate devices with the following ASTM Test standards: 1) F 1691, Standard Test Method for Determining the Axial Pull-Out Strength of Medical Bone Screws; 2) F 117, Standard Test Method for Driving Torque of Medical Bone Screws; and 3) F 1622, Standard Test Method for Measuring the Torsional Properties in Metallic Bone Screws.
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.
Not Found
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
10F2
510(K) SUMMARY
V
Pioneer Surgical Technology 510(K) Notification Summary: Cannulated Screw System by Pioneer
ADMINISTRATIVE INFORMATION
| Manufacturer Identification
And Sponsor | Pioneer Surgical Technology
375 River Park Circle
Marquette, Michigan 49855-1781
Telephone: (906) 226-9909
Facsimile: (906) 226-9932 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Amy H. Mommaerts, Manager
Regulatory Affairs |
Date Prepared ................................................................................................................................................................
DEVICE IDENTIFICATION
| Proprietary Name | Cannulated Screw System by Pioneer |
|---|---|
| Common Name: | Cannulated Screw |
| Classification Name | Screw, Fixation, Bone |
| And Reference | Screw, Fixation, Bone |
| Regulation Number | 888.3040 |
| Classification Number | 87HWC |
| Proprietary Name | Cannulated Screw System by Pioneer |
| Common Name: Screw | Washer |
| Classification Name | |
| And Reference: Screw | Washer, Bolt, Nut, Orthopaedic |
| Regulation Number | 888.3030 |
| Classification Number | 87HTN |
Devices on Which Substantial Equivalence is Claimed
The Cannulated Screw System by Pioneer is predicated on the ZIMMER MAGNA-Fx; the ZIMMER Mini MAGNA-Fx; and the Synthes Cannulated Screw System.
Device Description
The Cannulated Screw System by Pioneer consists of cannulated screws of varying diameters, lengths and thread configurations to accommodate variations in surgical technique and severity level of fracture. The system includes correspondingly sized washers, the use of which is optional. The cannulated screws are self-cutting and self-
1
K003496
2 OF 2
tapping in appropriate bone stock, which maximizes OR efficiency. The threads are tapping in approphato bone otew removal and decreasing the chance of breakage. reverse batting, faoilitating of engle use and will be offered both sterile and nonsterile.
Intended Use
The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:
- Fractures of the tarsals and metatarsals; 1.
- Metatarsal and phalangeal osteotomies; 2.
- Fractures of the carpals and metacarpals; 3.
- Carpal and metacarpal arthrodesis; ধ:
- Small fragments of the hand and wrist; 5.
- Ligament fixation; 6.
- Sacroillac ioint disruptions; 7.
- Fractures of the distal femur and proximal tibia; 8.
- Intracapsular fractures of the hip; 9.
-
- Ankle arthrodesis;
-
- Pelvis and acetabulum fractures; and
-
- Areas where accurate screw placement is vital.
This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.
Technological Characteristic Compared to Predicate Device
The Cannulated Screw system by Pioneer was designed referencing the following ASTM standards, similar to the predicate Zimmer Magna-FX, Mini Magna-FX and AO Hi Standardo, Similar to the production for Metallic Medical Bone Screws; and 2) F 116, Standard Specification for Medical Screwdriver Bits
Performance
r oreemianes
Based on the screw material equivalence in the proposed system an at least equivalent comparison has been logically derived from the information available.
Performance Data
The Cannulated Screw System by Pioneer is predicated on the use Zimmer Magna-FX and Synthes Cannulated screws. The Cannulated Screw system by Pioneer will be evaluated and compared to the predicate devices with the following ASTM Test standards: 1) F 1691, Standard Test Method for Determining the Axial Pull-Out Strength of Medical Bone Screws; 2) F 117, Standard Test Method for Driving Torque of Medical Bone Screws; and 3) F 1622, Standard Test Method for Measuring the Torsional Properties in Metallic Bone Screws.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right.
Public Health Service
FEB = 8 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Amy H. Mommaerts Manager, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855
Re: K003496 Trade Name: Cannulated Screw System Regulatory Class: II Product Codes: HTN and HWC Dated: November 10, 2000 Received: November 13 2000
Dear Ms. Mommaerts:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Sccubit 910(x) notifically equivalent (for the indications for use above and we have determined the correct in interstate commerce prior to May 28, 1976, the stated in the elieboute) to device Amendments, or to devices that have been reclassified in enactment date of the Medical Dovieo Frinentialized, brug, and Cosmetic Act (Act). The program accordance with the provisions of the reacted control provisions of the Act. The general therefore, market the device, subject to answal registration, listing of devices, control provisions of the fiel merilibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III 11 your device is classified (see acc re) and additional controls. Existing major regulations (Pleniance Apployal), it may of success to sates from the Code of Federal Regulations, Title 21, Parts 800 to 895. allecting your devroe can or remination assumes compliance with the current Good A substantially cquiralent covernent, 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 mspections, the Food and Drug Hammesult in regulatory action. In addition, FDA may publish Comply with the GMI Tegatator may readeral Register. Please note: this response to your premarket notification submission does not affect any obligation you might It spollse to your promation houseaus 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 I his letter will anow you to ocgin maxantial equivalence of your device to a legally marketed nontication. The I Driving sification for your device and thus, permits your device to proceed to the market.
3
Page 2 - Ms. Amy H. Mommaerts
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for in Vitro diagnostic no nother promotion and advertising of your device, (301) 594-4659. Additionally, for questions of the pressent the regulation please contact the Office of Compliance at (301) ->++0.5: "(21 CFR 807.97). Other general
entitled, "Misbranding by reference to premarks obteined from the Division of Small entitled, "Misbranding by reference up perilance. Inonited from the Division of Small
information on your responsibilities under the Act may be obtained from the Division of information on your responsibilites under (800) 638-2041 or at (301) 443-6597, or at its
Manufacturers Assistance at its toll-free 111 Mandracturers 715siblantes av fda.gov/cdrh/dsmamain.html".
Sincerely yours,
L. Mark N. Milkman
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
Page of
510(k) NUMBER (IF KNOWN): K003496
DEVICE NAME: Cannulated Screw
INDICATIONS FOR USE:
The Cannulated Screw System by Pioneer will be indicated for use in long and small bone fracture fixation, which may include the following:
-
- Fractures of the tarsals and metatarsals;
-
- Metatarsal and phalangeal osteotomies;
-
- Fractures of the carpals and metacarpals;
-
- Carpal and metacarpal arthrodesis;
-
- Small fragments of the hand and wrist;
-
- Ligament fixation as appropriate;
-
- Sacroiliac joint disruptions;
-
- Fractures of the distal femur and proximal tibia;
-
- Intracapsular fractures of the hip;
-
- Ankle arthrodesis; and
-
- Pelvis and acetabulum fractures;
This system is not indicated for use in the spine. The Cannulated Screw System by Pioneer will be offered both sterile and non-sterile and is a single use device.
AhMounacb- 01/22/01
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
for Mark N Melkers
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number.