(20 days)
Not Found
No
The description focuses on the mechanical aspects of a bone screw fixation system and its intended surgical uses. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
A therapeutic device is one that treats a disease or condition. This device is a bone screw fixation system intended for soft tissue fixation to bones during surgical procedures for various instabilities, which is a supportive and reparative function rather than a therapeutic one.
No.
The device is a surgical fixation system used for repairing soft tissue to bone, not for diagnosing conditions.
No
The device description clearly describes a system involving bone screws and inserters, which are physical hardware components used in surgical procedures. There is no mention of software as the primary or sole component of the device.
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 "soft tissue fixation to bones by means of bone screws threaded with sutures" during surgical procedures. This is a mechanical function performed directly on the patient's body.
- Device Description: The description reinforces the mechanical nature of the device, focusing on bone screws and sutures for fixation.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical tool used for physical repair within the body.
N/A
Intended Use / Indications for Use
The Straight-In - Orthopedic Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures.
It is indicated for use during surgical procedures where soft tissue fixation to bones is needed, such as:
-
- Repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromiociavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction.
-
- Repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation.
-
- Repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament.
-
- Repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis.
-
- Repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
Product codes
MBI, HWC
Device Description
The design and materials of the Orthopedic Straight-In and Short shaft Straight-In systems are identical. The differences are that the Inserter of the Orthopedic Straight-In is designed for use in 10 procedures, while the predicate device is designed for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Hand/Wrist, Knee, Foot/Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical procedures
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
Information and performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance.
Key Metrics
Not Found
Predicate Device(s)
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
1 1999 FEB
510(k) Summary of Safety and Effectiveness Influence, Inc.'s Orthopedic Straight-In Bone Screw Fixation System 510(k) Number _)( 990095
This 510(k) notification is submitted by Influence, Inc., 71 Stevenson Street, Suite 1120, San Francisco, California 94105. The contact person is Peter Bick, Sunce President and CEO.
This 510(k) notification describes a device intended for soft tissue fixation to bones by means of bone screws threaded with sutures. The Orthopedic Straight-In Bone Screw Fixation System is indicated for use during surgical procedures where soft tissue fixation to bones is needed, such as:
- l . Repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromiociavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction.
-
- Repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation.
-
- Repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament.
-
- Repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis.
-
- Repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
The Struight-In -- Orthopedic Bone Screw Fixation System is substantially equivalent 1000155 Short Shaft Shaft Shaft Straight-In Bone Screw System cleared under K982155. The design and materials of the Orthopedic Straight-In and Short shaft Straight-In systems are identical. The differences are that the Inserter of the Orthopedic Straight-In is designed for use in 10 procedures, while the predicate device is designed for single use. The Orthopedic device is substantially equivalent to the Anchorlok™ Soft tissue anchor system cleared under K971282 with respect to intended use and performance of the bone screws.
Information and performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance.
Based on the information provided, the Straight-In Orthopedic Bone Screw Fixation System is substantially equivalent to the Short Shaft Straight-In and to the Anchorlok™ devices with respect to intended use, technological characteristics, and performance.
1
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
Straight-In - Orthopedic Bone Screw System
The Straight-In - Orthopedic Rone Screw Fixation System is intended for soft tissue fixation to bones by means of bonc screws threaded with sutures.
It is indicated for use during surgical procedures where soft tissue fixation to bones is needed, such as:
-
- Repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromiociavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction.
-
- Repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation.
-
- Repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament.
-
- Repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis.
-
- Repair of foot/ankle instability secondary to tcar or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
(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 General and Restorative Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use
49
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1999 FEB
Peter A. Bick, M.D. President and CEO Influence, Inc. Suite 1120 71 Stevenson Street, San Francisco, California 94105
Re : K990095 Straight-In-Orthopedic Bone Screw Trade Name: Fixation System Requlatory Class: II MBI and HWC Product Code: December 31, 1998 Dated: Received: January 12, 1999
Dear Dr. Bick:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your 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.
3
Page 2 - Peter A. Bick, M.D.
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.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil RTOgden, for
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
K 990095
510(k) Number (if known):
Device Name:
Indications for Use:
Straight-In - Orthopedic Bone Screw System
The Straight-In - Orthopedic Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures.
It is indicated for use during surgical procedures where soft tissue fixation to bones is needed, such as:
-
- Repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromiociavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction.
-
- Repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation.
-
- Repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament.
-
- Repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis.
-
- Repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ ligaments. midfoot tendons/ligaments, or metatarsal tendons/ligaments.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (Division Sign-off) Division of General and Restorative D
510(k) Number
Prescription Use (Per 21 CFR 801.109)
ﺳﮯ
OR
Over the Counter Use