(22 days)
Not Found
No
The summary describes a physical suture anchor and inserter system for soft tissue repair, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an absorbable disposable suture anchor assembly for soft tissue repair to bone, which performs a therapeutic function by stabilizing injured soft tissue and promoting healing.
No
The device is described as a surgical anchor for soft tissue to bone fixation, used in repair procedures rather than for diagnosing conditions.
No
The device description clearly states it is a "preloaded, absorbable disposable suture anchors/ inserters assembly," which are physical hardware components used for surgical repair.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for soft tissue to bone fixation in various anatomical locations (shoulder, knee, ankle, foot, and elbow) during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as a "preloaded, absorbable disposable suture anchors/inserters assembly." This is a physical implantable device used to secure tissue.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or diagnostic purposes.
The device described is a surgical implant used for mechanical fixation within the body, which falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Bioknotless Plus Anchor: The Bioknotless Plus Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER 1. Bankart repair - 2. SLAP lesion repair 3. Rotator cuff repair - 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site - 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus - 5. Biceps tenodesis 6. Acromio-clavicular separation 7. Deltoid repair ELBOW - 1. Biceps tendon reattachment - 2. Tennis elbow repair ANKLE - 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the medial talus site - Foot: Hallux Valgus reconstruction 4. Midfoot reconstruction KNEE - 1. Medial collateral ligament repair - 2. Lateral collateral ligament repair - 3. Joint 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. ARTHROSCOPIC PROCEDURES SHOULDER - 1. Bankart repair - 2. SLAP lesion repair - 3. Rotator cuff repair - 4. Capsule shift repair (glenoid rim)
Lupine Plus Anchor: The Lupines Plus The Lupine Loop Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER - 1. Bankart repair 2. SLAP lesion repair 3. Rotator cuff repair 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus 5. Biceps tenodesis 6. Acromio-clavicular separation 7. Deltoid repair ELBOW 1. Biceps tendon reattachment 2. Tennis elbow repair ANKLE 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the medial talus site Foot: Hallux Valgus reconstruction 4. Midfoot reconstruction KNEE 1. Medial collateral ligament repair 2. Lateral collateral ligament repair 3. Joint 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. ARTHROSCOPIC PROCEDURES SHOULDER 1. Bankart repair 2. SLAP lesion repair 2. SLAP lesion repair 3. Rotator cuff repair 3. Rotator cuff repair 4. Capsule shift repair (glenoid rim)
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC, JDR
Device Description
Bioknotless Plus Anchor / Lupine Plus are a preloaded, absorbable disposable suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Bionotless Anchor / Lupine Anchor in design and configuration. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor systems may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, knee, ankle, foot, elbow
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 Bioknotless Anchor Plus / Lupine Anchor Plus 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.
Bioknotless Anchor, K002639, Lupine Anchor, K050771
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
K062170 page 142
510(k) SUMMARY
AUG 2 2 2006
Bioknotless Plus Anchor / Lupine Plus Anchor
| 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: 508-977-6955
e-mail: KChristo@Dpyus.jnj.com |
| Name of Medical Device | Classification Name: Screw, Fixation, Bone Staple
Common/Usual Name: Appliance for reconstruction of soft
tissue to bone
Proprietary Name: Bioknotless Anchor / Lupine Anchor |
| Substantial Equivalence | Bioknotless Plus Anchor is substantially equivalent to:
Bioknotless Anchor, K002639, manufactured by DePuy Mitek.
Lupine Plus Anchor is substantially equivalent to:
Lupine Anchor, K050771, 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
metallic bone fixation appliances and accessories.
Bioknotless Anchor / Lupine Anchor Systems carry FDA product code
MAI and is classified as single / multiple component metallic bone
fixation appliances and accessories soft tissue fastener under 21 CFR
888.3030. |
| Device Description | Bioknotless Plus Anchor / Lupine Plus are a preloaded, absorbable |
Bioknotless Anchor Plus / Lupine Anchor Plus
1
disposable suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Bionotless Anchor / Lupine Anchor in design and configuration. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor systems may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298). The Bioknotless Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder, knee, ankle, foot, elbow The Lupine Anchor is indicated for use in soft tissue to bone
fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair,2. SLAP lesion repair 3. Rotator cuff repair, 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site, 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus, 5. Biceps tenodesis, 6. Acromio-clavicular separation, 7. Deltoid repair ELBOW: 1. Biceps tendon reattachment, 2. Tennis elbow repair ANKLE: 1. Achilles tendon repair/reconstruction, 2. Lateral stabilization 3. Medial stabilization at the medial talus site, Foot: Hallux Valgus reconstruction, 4. Midfoot reconstruction KNEE: 1. Medial collateral ligament repair, 2. Lateral collateral ligament repair 3. Joint 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. ARTHROSCOPIC PROCEDURES SHOULDER:1. Bankart repair, 2. SLAP lesion repair, 3. Rotator cuff repair, 4. Capsule shift repair (glenoid rim)
Safety and Performance The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the Bioknotless Anchor Plus / Lupine Anchor Plus met predetermined acceptance criteria.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Bioknotless Anchor Plus and Lupjne Anchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Indications for Use
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. 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
AUG 2 2 2006
DePuy Mitek A Johnson & Johnson Company % Ms. Kristine Christo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts
Re: K062170
Trade/Device Name: Bioknotless Plus Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and acessories Regulatory Class: Class II Product Code: HWC, JDR, MAI Dated: July 28, 2006 Received: July 31, 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.
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); 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.
3
Page 2 - Ms. Kristine Christo
ﻟ
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, permits 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" (21 CFR 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,
Paulare Buell
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
page 192
INDICATIONS FOR USE
510(k) Number (if known): K062 | 70
Device Names: Bioknotless Plus Anchor
Indications for Use: The Bioknotless Plus Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
OPEN PROCEDURES SHOULDER
- Bankart repair
-
- SLAP lesion repair
- Rotator cuff repair
- 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site
- 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
-
- Biceps tenodesis
-
Acromio-clavicular separation
-
Deltoid repair
ELBOW
-
- Biceps tendon reattachment
-
- Tennis elbow repair
ANKLE
-
- Achilles tendon repair/reconstruction
-
Lateral stabilization
-
Medial stabilization at the medial talus site
- Foot: Hallux Valgus reconstruction
- Midfoot reconstruction
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)
Over-The-Counter Use
(Part 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 Ey Distismon (0) Say Page 1 of Division of Ge and Neurological Devices
510(k) Number K062170
5
INDICATIONS FOR USE
510(k) Number (if known): Kobo2170
Device Names: Lupine Plus Anchor
INDICATIONS FOR USE: The Lupines Plus The Lupine Loop Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
OPEN PROCEDURES SHOULDER
-
- Bankart repair
-
SLAP lesion repair
-
Rotator cuff repair
4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site
4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
-
Biceps tenodesis
-
Acromio-clavicular separation
-
Deltoid repair
ELBOW
-
Biceps tendon reattachment
-
Tennis elbow repair
ANKLE
-
Achilles tendon repair/reconstruction
-
Lateral stabilization
-
Medial stabilization at the medial talus site
Foot: Hallux Valgus reconstruction
- Midfoot reconstruction
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
-
SLAP lesion repair
-
Rotator cuff repair
-
Rotator cuff repair
-
Capsule shift repair (glenoid rim)
| 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)
Page 1 of __________
| (Division Sign-Off) | |
|---|---|
| -- | ----------------------------------------- |
510(k) Premarket Notification: Special
Bioknotless Anchor Plus / Lupine Anchor Plus
Division of General, Restorative,
and Neurological Devices
510(k) Number K062170