(29 days)
No
The device description and intended use focus on the physical characteristics and surgical applications of a suture anchor, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for use in soft tissue to bone fixation for various repairs and reconstructions, which are therapeutic interventions.
No
The device is a suture anchor used for the fixation of soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "preloaded, disposable suture anchors/ inserters assembly," indicating it is a physical medical device made of materials like Biocryl Rapide and suture.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical device used for soft tissue to bone fixation in various anatomical locations (shoulder, knee, ankle, foot, and elbow). This is a direct surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a "preloaded, disposable suture anchors/ inserters assembly" made of a biocomposite material. This is consistent with a surgical implant used for mechanical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Bioknotless BR Anchor / Lupine BR Anchor is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bioknotless 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) 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)
Product codes (comma separated list FDA assigned to the subject device)
MAI, GAM, GAS, GAT
Device Description
Bioknotless BR Anchor / Lupine BR are a preloaded, disposable suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The anchor is dimensionally identical anchor to that of the Bionotless Anchor Plus / Lupine Anchor Plus. The anchor material is changing from absorbable polylactic acid (PLA) in the predicate device to Biocryl Rapide a B-TCP/PLGA biocomposite material in the proposed devise. The anchor is a one piece suture anchor sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
Biocryl Rapid, a ß-TCP/PLGA biocomposite material is currently used in the Mitek Milagro Screw (K032717, K060830) which is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. Additionally, the 7, 8 and 9 mm x23 mm Mitek Milagro screws are indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, knee, ankle, foot, elbow, anterior glenoid rim site, lesser tuberosity of the humerus, medial talus site, anterior proximal tibia, glenoid rim
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 BR Anchor / Lupine BR Anchor 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.
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
510(k) SUMMARY
MAY - 2 2007
Bioknotless BR Anchor / Lupine BR 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 BR Anchor is substantially equivalent to:
Bioknotless Plus Anchor, K062170, manufactured by DePuy Mitek.
RapideLupine Anchor is substantially equivalent to:
Lupine Plus Anchor, K062170, 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 BR Anchor / Lupine BR are a preloaded, disposable | | |
510(k) Premarket Notification: Special Bioknotless BR Anchor / Lupine BR Anchor Confidential
1
suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The anchor is dimensionally identical anchor to that of the Bionotless Anchor Plus / Lupine Anchor Plus. The anchor material is changing from absorbable polylactic acid (PLA) in the predicate device to Biocryl Rapide a B-TCP/PLGA biocomposite material in the proposed devise. The anchor is a one piece suture anchor sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
Biocryl Rapid, a ß-TCP/PLGA biocomposite material is currently used in the Mitek Milagro Screw (K032717, K060830) which is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. Additionally, the 7, 8 and 9 mm x23 mm Mitek Milagro screws are indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
Indications for Use
The Bioknotless 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) 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
Confidential
2
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 BR Anchor / Lupine BR Anchor met predetermined acceptance criteria.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Bioknotless BR Anchor and Rapide Lupjne Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
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
Re: K070925 Trade/Device Names: Bioknotless BR Anchor Lupine BR Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI, GAM, GAS, GAT Dated: April 2, 2007 Received: April 3, 2007
MAY - 2 2007
Dear Ms. Christo:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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
4
Page 2 - Ms. Kristine Christo
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 vours.
Douglare Buellm
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): K070925
Device Names: Bioknotless BR Anchor
Indications for Use: The Bioknotless BR 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)
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(19)
(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 BR Anchor / Lupine BR Anchor | Division of General, Restorative, Confidential and Neurological Devices |
510(k) Number_KO 70925
6
INDICATIONS FOR USE
510(k) Number (if known): K070925
Device Names: Lupine BR Anchor
INDICATIONS FOR USE: The Lupine BR Anchor 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)
Prescription Use V (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
510(k) Premarket Notification: Special Bioknotless BR Anchor / Lupine BR Anchor Confidential