(23 days)
Not Found
No
The device description and intended use clearly describe a mechanical suture anchor system for soft tissue to bone fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a suture anchor system used for soft tissue to bone fixation, which is a surgical repair tool rather than a therapeutic device that provides treatment.
No
The document describes a surgical device intended for fixing soft tissue to bone. It is used for repair and reconstruction procedures, not for diagnosis.
No
The device description clearly states it is a "disposable suture anchor/ inserter assemblies," which are physical hardware components used in surgical procedures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (suture anchor) used for fixing soft tissue to bone during surgical procedures like rotator cuff repair. This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, diagnostic information, or laboratory procedures, which are hallmarks of IVDs.
Therefore, based on the provided information, the Mitek Panalok RC QuickAnchor Plus and Mitek Panalok Anchor systems are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Mitek Panalok RC QuickAnchor Plus with Orthocord and Mitek Panalok RC QuickAnchor Plus Dual Suture with Orthocord are intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: rotator cuff repair
The Mitek Panalok Anchor with Orthocord are indicated for use in soft tissue to bone fixation in association with adequate post- operative immobilization as follows:.
Open Procedure Shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair, capsule shift/ capsulo-labral reconstruction at anterior glenoid rim site, 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, joint 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 (comma separated list FDA assigned to the subject device)
JDR, MAI
Device Description
Panalok RC Anchor Plus (with ORTHOCORD), Panalok RC Anchor Plus Dual Suture (with ORTHOCORD) and Panalok are preloaded, PLA disposable suture anchor/ inserter assemblies designed to allow soft tissue repair to bone. The anchors are an identical anchors as that of the Panalok RC Anchor Plus (K041117) and Panalok Anchor (K970896) in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture, Panacryl Suture, Orthocord Suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Ankle, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria.
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.
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
NOV 2 2 2006
510(k) SUMMARY
Panalok RC Quickanchor Plus w/ Orthocord Panalok RC Quickanchor Plus Dual w/ Orthocord Panalok Anchor w/ Orthocord
| Submitter's Name and
Address: | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kristine Christo
Senior Regulatory Affairs Specialist
DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
| | Telephone:
508-828-3359
Facsimile:
508-977-6911
e-mail:
KChristo@Dpyus.jnj.com |
| Name of Medical Device | Classification Name:
Screw, Fixation, Bone Staple
Fastener, Fixation, Biodegradable, Soft Tissue |
| | Common/Usual Name:
Appliance for reconstruction of soft
tissue to bone |
| | Proprietary Name:
Panalok Quickanchor Plus
Panalok RC QuickAnchor Plus Dual Suture
Panalok Anchor |
| Substantial Equivalence | Panalok RC Quickanchor Plus (with ORTHOCORD) and Panalok RC
Quickanchor Plus Dual Suture (with ORTHOCORD) are substantially
equivalent to:
Panalok RC Quickanchor Plus, K041117 , manufactured by DePuy
Mitek. |
| | Panalok Anchor (with ORTHOCORD) is substantially equivalent to:
Panalok Anchor, K970896 , manufactured by DePuy Mitek. |
| Device Classification | Bone anchors/screws are classified by the FDA as Class II Medical
Devices under the generic category of Single/Multiple component |
| 510(k) Premarket Notification: Special | Confidential |
| | metallic bone fixation appliances and accessories. |
| | Panalok RC Quickanchor Plus carry FDA product code JDR, and is
classified as a fixation screw/bone staple under 21 CFR 888.3030. |
| | Panalok Anchor carry FDA product code MAI, and is classified as a
Fastener, fixation biodegradable, soft tissue under 21 CFR 888.3030 |
| Device Description | Panalok RC Anchor Plus (with ORTHOCORD), Panalok RC Anchor
Plus Dual Suture (with ORTHOCORD) and Panalok are preloaded,
PLA disposable suture anchor/ inserter assemblies designed to allow
soft tissue repair to bone. The anchors are an identical anchors as that
of the Panalok RC Anchor Plus (K041117) and Panalok Anchor
(K970896) in design, configuration and dimensions. The anchor
system may be sold with Ethibond Suture, Panacryl Suture, Orthocord
Suture. |
| Indications for Use | The Mitek Panalok RC QuickAnchor Plus with Orthocord and Mitek
Panalok RC QuickAnchor Plus Dual Suture with Orthocord are
intended for fixation of USP size #2 suture to bone for the indications
listed below.
Shoulder: rotator cuff repair |
| | The Mitek Panalok Anchor with Orthocord are indicated for use in soft
tissue to bone fixation in association with adequate post- operative
immobilization as follows:. |
| | Open Procedure Shoulder: Bankart repair, SLAP lesion repair, rotator
cuff repair, capsule shift/ capsulo-labral reconstruction at anterior
glenoid rim site, 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, joint 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) |
1
Confidential
2
Safety and Performance The determination of substantial equivalence for these devices were based on a detailed device descriptions, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Panalok RC Quickanchor Plus (with ORTHOCORD), Panalok RC Quickanchor Plus Dual Suture (with ORTHOCORD) and Panalok Anchor (with ORTHOCORD) have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Confidential
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Mitek, a Johnson & Johnson Company % Ms. Kristine Christo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
NOV 2 2 2006
Re: K063273
Trade/Device Name: Panalok RC QuickAnchor Plus with Orthocord, Panalok RC OuickAnchor Plus Dual Suture with Orthocord, and Panalok Anchor with Orthocord Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, MAI Dated: October 27, 2006 Received: October 30, 2006
Dear Ms. Christo:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Kristine Christo
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 af 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); 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. This letter will allow you to begin marketing your device as described in your Section 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, permite your device to proceed to the market,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Janbare Prelin
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K063273
Device Names: Panalok RC Quickanchor Plus, with Orthocord Panalok RC Quickanchor Plus Dual Suture with Orthocord
Indications for Use:
The Mitek Panalok RC QuickAnchor Plus with Orthooord and Mitek Panalok RC QuickAnchor Plus Dual Suture with Orthocord are intended for fixstion and Mitts I allation RC QuickAnchor Plus Dual
Suture with Orthocord are intended for fixation of USP size #2 suture to bone fo
Shoulder: rotator cuff repair
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Darlene Brens
Page 1 of
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062273
Confidential
6
INDICATIONS FOR USE
510(k) Number (if known):
Device Names: Panalok Anchor with Orthocord
Indications for Use:
The Mitek Panalok Anchor with Orthocord are indicated for use in soft tissue to bone fixation in association with adequate post- operative immobilization as follows:.
Open Procedure Shoulder: Bankart repair, SLAP Iesion repair, capsule shift/ capsule shift/ capsulo-labral reconstruction at anterior glenoid rim site, shift/capsulo-labral repair, at the lesser tubero cats of the humerus, , biceps tenodesis, acromio-clavicular separation .
Elbow: Biceps tendon reattachment
Ankle: Achilles tendon repair/reconstruction, lateral stabilization at the medial talus site
Knee: Medial collateral ligament repair, lateral ligament repair, joint capsule closure to anterior proximal tibia, posterior oblique ligament or joint capsule to tibia repair, extra capsular reconstruction / ITR tenodesis, patellar ligament and tendon avulsion repairs
Arthroscopic Procedures shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair, , capsule shift repair (glenoid rim)
Prescription Use 1 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page 1 of
Confidential
510(k) Premarket Notification: Special Panalok RC Quickanchor Plus With Orthocord Dual Suture Panalok RC Quickanchor Plus With Orthocord Panalok Anchor With Orthocord
51