(88 days)
Not Found
No
The document describes surgical instruments made of stainless steel for use with interference screws and does not mention any AI or ML capabilities.
No.
The device described is an arthroscopic surgical instrument used to facilitate the implantation of interference screws for reattachment of tissues to bone, not a therapeutic device itself. Its classification is based on the therapeutic devices it aids in implanting.
No
The device is described as "surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems". Its indications are for the reattachment of ligament, tendon, or soft tissue to bone, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states the instruments are manufactured from medical grade Stainless Steel, indicating they are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that these are "arthroscopic surgical instruments" and "accessory devices" used in surgery to facilitate the implantation of interference screws.
- Intended Use: The intended use is for surgical procedures to reattach ligaments, tendons, or soft tissue to bone. This is a direct surgical intervention on the body, not an examination of a specimen outside the body.
The device is a surgical instrument used during surgery, not a diagnostic tool used to analyze samples in vitro.
N/A
Intended Use / Indications for Use
Smith & Nephew Arthroscopic Surgical Instruments—Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following:
Shoulder:
Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot/Ankle:
Hallux Valgus, Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers.
Elbow/Hand/Wrist:
Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon/Repair
Knee:
Medial or Lateral Collateral ligament, Posterior oblique ligament, Vasus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair.
The Smith & Nephew BIOSURE PK Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less and a length of 25mm or less are also intended for use in the following procedures:
Knee
- ACL Repairs .
- PCL Repairs .
- Extra-capsular repairs .
- o Medial collateral ligament
- o Lateral collateral ligament
- Posterior oblique ligament o
- Patellar realignment and tendon repairs t Vastus medialis obliquous advancement o
- Iliotibial band tenodesis .
Shoulder
- Capsular stabilization ●
- Bankart repair o
- Anterior shoulder instability o
- SLAP lesion repairs 0
- Capsular shift or capsulolabral reconstructions o
- Acromioclavicular separation repairs
- Deltoid repairs
- Rotator cuff tear repairs .
- Biceps tenodesis .
Foot and Ankle
- Hallux valgus repairs .
- Medial or lateral instability repairs/reconstructions .
- Achilles tendon repairs/reconstructions .
- Midfoot reconstructions
- Metatarsal ligament/tendon repairs/reconstructions .
- Bunionectomy .
- Flexor Hullucis Longus (FLH) .
- Tendon Transfers 0
Elbow, Wrist, and Hand
- · Biceps tendon reattachment
- Ulnar or radial collateral ligament reconstructions .
- Lateral epicondylitis repair ●
- Scapholunate ligament reconstruction .
- Tendon Transfers ●
- Carpometacarpal Joint Arthroplasty .
- Carpal Ligament Reconstruction
The Smith & Nephew HA-PLA Interference Screw is indicated for fixation of bone-tendonbone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery.
The Cannu-Flex Silk Screw is an Interference Screw, indicated for tendon/ligament graft fixation.
- The Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or 1. soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
- . The screw is indicated for single use only. 2.
RCI Fixation Screws are used for interference fixation of Bone-Tendon-Bone or soft tissue grafts in anterior or posterior cruciate ligament reconstruction.
Product codes
HWC, MBI, MAI
Device Description
The subject device specific arthroscopic surgical instruments associated with the Smith & Nephew Interference Screw Systems are accessory devices and take on the classification of the device(s) with which they are used. The Drivers, Taps, Screw Starters, and Routers are all manufactured from medical grade Stainless Steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Elbow/Hand/Wrist, Knee
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
The subject device specific arthroscopic surgical instruments associated with the Smith & Nephew Interference Screw Systems have the same intended use, technological and performance characteristics as the legally marketed predicate devices. The product designs are in conformance with the recognized consensus standards identified in this submission and do not raise any new issues of safety and efficacy.
Key Metrics
Not Found
Predicate Device(s)
K083226, K083635, K002274, K921481, K984320, K992945
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Kda25 96 #1|2
Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA
T 978-749-1000 F 978-749-1443 www.smith-nephew.com " We are smith&nephew
510(k) Summary
Smith & Nephew Interference Screw Systems Instruments
1. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
2. Company Contact
Sean Reynolds Manager, Regulatory Affairs Phone: (978) 749-1173 FAX: (978)-749-1443
3. Device Name
| Trade Name: | Arthroscopic Surgical Instruments—Interference Screw Systems |
|---|---|
| Common Name: | Smooth or threaded metallic bone fixation fastener |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
4. Predicate Devices
The subject device specific arthroscopic surgical instruments associated with the Smith & Nephew Interference Screw Systems described in this premarket notification are considered substantially equivalent to the cleared devices identified in Table 1.
| Description | 510(k) | Clearance Date |
|---|---|---|
| Smith & Nephew PEEK Interference Screws | K083226 | 1/30/2009 |
| Smith & Nephew Biosure PK Interference Screw | K083635 | 1/30/2009 |
| Smith & Nephew HA-PLA Interference Screw | K002274 | 3/7/2001 |
| Smith & Nephew Cannu-Flex Interference Screws | K921481 | 8/24/1993 |
| Smith & Nephew Bioabsorbable Interference Screw | K984320 | 1/28/1999 |
| Smith & Nephew RCI Fixation Screws | K992945 | 9/1/1999 |
Table 1: Summary of Predicate Device Clearance Information
1
K122596 # 2/d
When compared to previously cleared device specific instruments, the proposed instruments utilize the same raw materials, manufacturing processes, and have the same intended use and nature of body contact.
The subject device specific arthroscopic surgical instruments associated with the Smith & Nephew Interference Screw Systems are similar in design, function and intended use to competing interference screw surgical instrumentation on the market.
5. Description of Device
The subject device specific arthroscopic surgical instruments associated with the Smith & Nephew Interference Screw Systems are accessory devices and take on the classification of the device(s) with which they are used. The Drivers, Taps, Screw Starters, and Routers are all manufactured from medical grade Stainless Steel.
6. Intended Use
Smith & Nephew Arthroscopic Surgical Instruments—Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
7. Comparison of Technological Characteristics
The subject device specific arthroscopic surgical instruments associated with the Smith & Nephew Interference Screw Systems are substantially equivalent in design, materials, and intended use to previously cleared device specific instruments. The subject device specific arthroscopic surgical instruments are used in conjunction with the interference screw systems detailed in Table 1.
The subject device specific arthroscopic surgical instruments associated with the Smith & Nephew Interference Screw Systems do not incorporate any new technological characteristics as compared to legally marketed devices. The instruments which are the subject of this submission are existing instruments that are currently marketed in the United States as Class I devices. The purpose of this submission is to bring those instruments into compliance with FDA's current policy. The recommended surgical techniques associated with the predicate device systems have not been changed or modified as a result of this 510(k).
8. Summary Performance Data
The subject device specific arthroscopic surgical instruments associated with the Smith & Nephew Interference Screw Systems have the same intended use, technological and performance characteristics as the legally marketed predicate devices. The product designs are in conformance with the recognized consensus standards identified in this submission and do not raise any new issues of safety and efficacy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 20, 2012
Smith & Nephew, Incorporated % Mr. Sean Reynolds Manager, Regulatory Affairs 150 Minuteman Road Andover, Massachusetts 01810
Re: K122596
Trade/Device Name: Arthroscopic Surgical Instruments - PEEK Interference Screws Systems Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, MAI Dated: August 20, 2012 Received: August 24, 2012
Dear Mr. Reynolds:
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Sean Reynolds
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 N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Arthroscopic Surgical Instruments-PEEK Interference Screws Indications for Use:
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following:
Shoulder:
Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot/Ankle:
Hallux Valgus, Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers.
Elbow/Hand/Wrist:
Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon/Repair
Knee:
Medial or Lateral Collateral ligament, Posterior oblique ligament, Vasus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair.
Prescription Use X AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices 2012.11.19 14:11:24 -05'00' 81.G
5
510(k) Number (if known):
Device Name: Arthroscopic Surgical Instruments- BIOSURE PK Interference Screws Indications for Use:
KI2254
Smith & Nephew Arthroscopic Surgical Instruments—Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
The Smith & Nephew BIOSURE PK Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less and a length of 25mm or less are also intended for use in the following procedures:
Knee
- ACL Repairs .
- PCL Repairs .
- Extra-capsular repairs .
- 0 Medial collateral ligament
- o Lateral collateral ligament
- Posterior oblique ligament o
- Patellar realignment and tendon repairs t Vastus medialis obliquous advancement o
- Iliotibial band tenodesis .
Shoulder
- Capsular stabilization ●
- Bankart repair o
- Anterior shoulder instability o
- SLAP lesion repairs 0
- Capsular shift or capsulolabral reconstructions o
- Acromioclavicular separation repairs
- Deltoid repairs
- Rotator cuff tear repairs .
- Biceps tenodesis .
Foot and Ankle
- Hallux valgus repairs .
- Medial or lateral instability repairs/reconstructions .
- Achilles tendon repairs/reconstructions .
- Midfoot reconstructions
6
- Metatarsal ligament/tendon repairs/reconstructions .
- Bunionectomy .
- Flexor Hullucis Longus (FLH) .
- Tendon Transfers 0
Elbow, Wrist, and Hand
- · Biceps tendon reattachment
- Ulnar or radial collateral ligament reconstructions .
- Lateral epicondylitis repair ●
- Scapholunate ligament reconstruction .
- Tendon Transfers ●
- Carpometacarpal Joint Arthroplasty .
- Carpal Ligament Reconstruction
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
. (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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
2012.11.19 14:10:20 -05'00'
7
A -1
510(k) Number (if known):
Device Name: Arthroscopic Surgical Instruments-HA-PLA Interference Screw Indications for Use:
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
The Smith & Nephew HA-PLA Interference Screw is indicated for fixation of bone-tendonbone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(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)
2012.11.19 14:12:21 Anton E. Dmitriev, PhD Division of Orthopedic Devices
8
510(k) Number (if known):
Device Name: Arthroscopic Surgical Instruments--- CANNU-FLEX Interference Screws
Indications for Use:
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
The Cannu-Flex Silk Screw is an Interference Screw, indicated for tendon/ligament graft fixation.
Prescription Use X
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
ટર
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices 2012.11.19 14:16:22 -05'00'
9
510(k) Number (if known):
Device Name: Arthroscopic Surgical Instruments-Bioabsorbable Interference Screws
Indications for Use:
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
- The Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or 1. soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
- . The screw is indicated for single use only. 2.
Prescription Use X
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
2012.11.19 14:13:20 -05'00'
10
510(k) Number (if known):
Device Name: Arthroscopic Surgical Instruments- RCI Fixation Screws
Indications for Use:
Smith & Nephew Arthroscopic Surgical Instruments-Interference Screw Systems are surgical instruments used in arthroscopic surgery to facilitate the implantation of Interference Screw Systems for their cleared Indications for Use.
RCI Fixation Screws are used for interference fixation of Bone-Tendon-Bone or soft tissue grafts in anterior or posterior cruciate ligament reconstruction.
AND/OR
Prescription Use
(Per 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
2012.11.19 14:14:28 -05'00'