(90 days)
Not Found
Not Found
No
The device description and intended use focus on a physical implant and surgical tools, with no mention of software, data processing, or AI/ML capabilities.
Yes.
The device is a suture anchor system used for soft tissue to bone fixation, which is a therapeutic intervention aimed at repairing injuries and restoring function.
No
Explanation: The device is described as a "Suture Anchor System" intended for "soft tissue to bone fixation," which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical implantable device (suture anchor) made of absorbable polymer, along with associated physical components like sutures, needles, and an inserter. It also mentions the use of physical instruments (drill and drill guide) for installation. This is not a software-only 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 "soft tissue to bone fixation in association with adequate post-operative immobilization." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "Suture Anchor System" designed to be implanted within bone to secure soft tissue using sutures. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Modified Mitek 3.5mm Absorbable Suture Anchor System is intended for use in soft tissue to bone fixation in association with adequate post-operative immobilization.
The Mitek PANALOK 3.5mm Absorbable Anchor System is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows:
OPEN PROCEDURES
SHOULDER:
- Bankart repair
- SLAP lesion repair
- Rotator cuff repair
- a. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus - Biceps tenodesis
- Acromio-clavicular separation
ELBOW:
- Biceps tendon/reattachment
ANKLE:
- Achilles tendon repair/reconstruction
- Lateral stabilization
- Medial stabilization at the medial talus site
KNEE:
- Medial collateral ligament repair
- Lateral collateral ligament repair
- Join capsule closure to anterior proximal tibia
- Posterior oblique ligament or joint capsule to tibia repair
- Extra capsular reconstruction/ITB tenodesis
- Patellar ligament and tendon avulsion repairs
ARTHROSCOPIC PROCEDURES
SHOULDER:
- Bankart repair
- SLAP lesion repair
- Rotator cuff repair
- Capsule shift repair (glenoid rim)
Product codes
MAI
Device Description
The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System is designed to implant within a pre-drilled bone hole site and provide a means for firmly securing soft tissue to bone using sutures.
The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System includes a PLL (homopolymer poly (L(-)-lactide) anchor pre-threaded with ETHICON Absorbable poly (Llactide/glycolide) Surgical Suture, Undyed, two pre-attached surgical needles, and a pre-assembled disposable inserter. The system is supplied sterile and ready for use. Mitek instruments, drill and drill guide, are to be used to install the Mitek PANALOK 3.5mm Absorbable Suture Anchor. The drill bit creates a hole 3.5mm in diameter by 18mm deep.
Poly (L(-)-lactide) polymer is nonpyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue to bone fixation in shoulder, elbow, ankle, and 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
Nonclinical laboratory testing was performed to assess the in vitro and in vivo strength and failure modes.
Key Metrics
Not Found
Predicate Device(s)
Mitek 3.5mm Absorbable Suture Anchor System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS K970896
510(k) Summary of Safety and Effectiveness Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
NEW DEVICE NAME: Modified Mitek 3.5mm Absorbable Suture Anchor System
PREDICATE DEVICE NAME: Mitek 3.5mm Absorbable Suture Anchor System
510(k) SUMMARY
Device Description
The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System is designed to implant within a pre-drilled bone hole site and provide a means for firmly securing soft tissue to bone using sutures.
The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System includes a PLL (homopolymer poly (L(-)-lactide) anchor pre-threaded with ETHICON Absorbable poly (Llactide/glycolide) Surgical Suture, Undyed, two pre-attached surgical needles, and a pre-assembled disposable inserter. The system is supplied sterile and ready for use. Mitek instruments, drill and drill guide, are to be used to install the Mitek PANALOK 3.5mm Absorbable Suture Anchor. The drill bit creates a hole 3.5mm in diameter by 18mm deep.
Poly (L(-)-lactide) polymer is nonpyrogenic.
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued)
| Intended Use | The Modified Mitek 3.5mm Absorbable Suture Anchor System
is intended for use in soft tissue to bone fixation in association
with adequate post-operative immobilization. | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Indications Statement | The Mitek PANALOK 3.5mm Absorbable Anchor System is
indicated for use in soft tissue to bone fixation in association
with adequate post-operative immobilization as follows: | |
| OPEN PROCEDURES | | |
| SHOULDER: | | |
| | 1. | Bankart repair |
| | 2. | SLAP lesion repair |
| | 3. | Rotator cuff repair |
| | 4. | a. Capsule shift/capsulo-labral reconstruction at the
lesser tuberosity of the humerus |
| | | b. Capsule shift/capsulo-labral reconstruction at the
lesser tuberosity of the humerus |
| | 5. | Biceps tenodesis |
| | 6. | Acromio-clavicular separation |
| ELBOW: | | |
| | 1. | Biceps tendon/reattachment |
| ANKLE: | | |
| | 1. | Achilles tendon repair/reconstruction |
| | 2. | Lateral stabilization |
| | 3. | Medial stabilization at the medial talus site |
| KNEE: | | |
| | 1. | Medial collateral ligament repair |
| | 2. | Lateral collateral ligament repair |
| | 3. | Join capsule closure to anterior proximal tibia |
| | 4. | Posterior oblique ligament or joint capsule to tibia repair |
| | 5. | Extra capsular reconstruction/ITB tenodesis |
| | 6. | Patellar ligament and tendon avulsion repairs |
| | Continued on next page | |
:
2
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Indication Statement (continued) ARTHROSCOPIC PROCEDURES
SHOULDER:
- Bankart repair 1.
-
- SLAP lesion repair
-
- Rotator cuff repair
- Capsule shift repair (glenoid rim) 4.
vitro and in viyo strength and failure modes.
Technological Characteristics
The modified device has the same technological characteristics as the predicate device. There are no changes in chemistry, material or composition. When compared to the predicate device, it only differs in that the ETHICON Absorbable poly (Llactide/glycolide) Surgical Suture, Undyed is being attached to its anchor system.
Performance Data
Conclusions
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the predicate device under the Federal Food. Drug. and Cosmetic Act.
Nonclinical laboratory testing was performed to assess the in
Gregory Jones Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151
Date
Contact
March 10, 1997
Modified PANALOK Wedge Absorbable Suture Anchor System ETHICON, Inc.
(
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 1997
Mr. Gregory Jones Director, Requlatory Affairs ------Ethicon, Inc. P.O. Box 151 Somerville, New Jersey 08876-0151
参
Re : K970896 Trade Name: Mitek 3.5mm Panalok Wedqe Absorbable Suture Anchor System Regulatory Class: II Product Code: MAI Dated: March 10, 1997 Received: March 11, 1997
Dear Mr. Jones:
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 qeneral 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic
4
GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your w 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 Gontrol 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.
If you desire specific advice for your device on our labeling regulation (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,
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
5
510(k) Number (if known): Device Name:
Indications for Use:
学
Modified Mitek 3.5mm PANALOK Wedge Absorbable Suture Anchor System
The Modified Mitek 3.5mm PANALOK Wedge Absorbable Suture Anchor System is indicated for use in soft tissue to bone fixation in association with adequate post operative ------------------------------------------------------------------------------------------------------------------------immobilization as follows:
Open Procedures
Arthroscopic Procedures
Shoulder:
-
Bankart repair 2. Slap lesion repair
-
Rotator cuff repair
-
Capsule shift repair
(glenoid rim)
Shoulder:
-
- Bankart repair
-
- Slap lesion repair
-
- Rotator cuff repair
-
- a. Capsule shift/capsulolabral reconstruction, at the anterior glenoid rim site
INDICATION FOR USE
- b. Capsule shift/capsulolabral reconstruction at the lesser tuberosity of the humerus
-
- Biceps tenodesis
-
- Acromio-clavicular separation
Elbow:
-
- Bicep tendon reattachment
Ankle:
-
- Achilles tendon repair/reconstruction
-
- Lateral stabilization
-
- Medial stabilization at the talus site
Knee:
-
- Media! collateral ligament repair
-
- Lateral collateral ligament repair
-
- Joint capsule closure to the anterior proximal tibia
-
- Posterior oblique ligament or joint capsule to tibia repair
-
- Extra capsular reconstruction/ITB tenodesis
-
- Patellar ligament and tendon avulsion repairs
ﺮ ﺗﺒﺎﺭ ﭘﻪ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩ
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The Counter Use | X |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | ||||
| (Division Sign-Off) | (Optional Format 1-2-9G) | |||
| Division of General Restorative Devices | ||||
| 510(k) Number | K970891 |
Modified PANALOK Wedge Absorbable Suture Anchor System ETHICON, Inc.