(355 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biological compatibility of a physical suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a medical device intended to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, which qualifies it as a therapeutic device.
No
The device, the Flower Suture Anchor Set, is intended for soft tissue fixation and reattachment procedures, which are therapeutic actions, not diagnostic ones. It is a surgical implant used to aid in reconstructive procedures.
No
The device description clearly states it consists of physical components made of PEEK and UHMWPE, including anchors, sutures, and inserters. It also mentions accessories like taps and drill bit kits. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The device is a "Suture Anchor Set" consisting of physical anchors and sutures. This is a surgical implant/tool, not a reagent, instrument, or system intended for use in the in vitro examination of specimens derived from the human body.
- No mention of in vitro testing: The entire document focuses on the surgical application and performance of the device within the body. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Flower Suture Anchor Set falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease.
The FlowerAnchor. 3.0mm is indicated for use in soft tissue reattachment procedures in the shoulder, elbow, wristhand. foot/ankle and knee. Specific indications are as follows:
· Shoulder indications: Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
-
· Wrist/hand indications: Scapholunate ligament reconstruction.
· Foot/Ankle indications: Tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. -
· Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The FlowerAnchor, 5.0mm and FlowerAnchor, Knotless is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
• Shoulder indications: Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation,deltoid repair, biceps tenodesis.
- Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
· Foot/Ankle indications: Achilles tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
· Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Flower Suture Anchor Set consists of FlowerAnchor, 3.0mm, FlowerAnchor, 5.0mm, and FlowerAnchor, Knotless with lengths of 10mm and 17mm, respectively. The anchors are screw-like in shape and made of PEEK. The anchors are threaded with ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures. The 3.0mm and 5.0mm anchors, USP Size 0 and Size 2 sutures, and inserters and the Knotless anchor and inserter are supplied as a single assembly, sterilized by ethylene-oxide, nonpyrogenic, and ready-for-surgery.
Accessories of Taps and Drill Bit Kits are supplied sterile by means of gamma radiation with the Flower Suture Anchor Set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, elbow, wrist/hand, foot/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)
The Flower Suture Anchor Set was tested (worse case) in accordance with FDA's Draft Guidance Document for Testing Bone Anchor Devices. Testing consisted of Insertion, Pull out, and Fatigue in comparison to the predicate devices. The subject device was found to be equivalent to the predicate devices in such performance. Cytotoxicity testing was also separately performed on both the patientcontacting and non-patient-contacting components.
Additionally, the Flower Suture Anchor Set was evaluated according to the following standards:
- USP 41-NF36:2018 , Sutures Diameter .
- USP 41-NF36:2018 , Sutures Needle Attachment ●
- USP 41-NF36:2018 , Tensile Strength .
- ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process;
- ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity:
- ISO 10993-7, Ethylene oxide sterilization residuals .
- ISO 11135-1, Ethylene Oxide Sterilization .
- ISO 11137, Radiation Sterilization ●
- ANSI/AAMI ST72:2011/ (R)2016, Bacterial Endotoxins Test Methods, Routine ● Monitoring, And Alternatives To Batch Testing
In all instances, the Flower Suture Anchor Set functioned and test results demonstrated substantial equivalence with the cited predicate devices.
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.
K113299, K061863, K110229, K110230, K111590, K112991
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
§ 888.3040 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
October 7, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Flower Orthopedics Corporation Amanda Pentecost, Ph.D. RA/QA Engineer Flower Orthopedics Corp. 3973 Delp Street Memphis, Tennessee 38118
Re: K192949
Trade/Device Name: Flower Suture Anchor Set Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 10, 2020 Received: September 11, 2020
Dear Dr. Pentecost:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Laura Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192949
Device Name Flower Suture Anchor Set
Indications for Use (Describe)
The Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease.
The FlowerAnchor. 3.0mm is indicated for use in soft tissue reattachment procedures in the shoulder, elbow, wristhand. foot/ankle and knee. Specific indications are as follows:
· Shoulder indications: Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
-
· Wrist/hand indications: Scapholunate ligament reconstruction.
· Foot/Ankle indications: Tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. -
· Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The FlowerAnchor, 5.0mm and FlowerAnchor, Knotless is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
• Shoulder indications: Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation,deltoid repair, biceps tenodesis.
- Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
· Foot/Ankle indications: Achilles tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
· Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K192949 510(k) Summary Flower Suture Anchor Set
Submitter: Flower Orthopedics Corporation
100 Witmer Rd. Suite 280 Horsham PA, 19044
Phone: 215-394-8903 Facsimile: 215-394-8904
Contact Person: Amanda Pentecost, Ph.D. Date Prepared: September 29, 2020
Name of Device:
Flower Suture Anchor Set
Trade Name: Flower Suture Anchor Set
Common Name: Suture Anchor
Classification: Fastener, Fixation, Nondegradable, Soft Tissue (Product Code: MBI), Class II, Orthopedic Review Panel, 21 C.F.R. 888.3040
Predicate Devices:
| Manufacturer | Trade Name | 510K |
|---|---|---|
| Primary Predicate: | ||
| RoG Sports Medicine Inc. | Rog Suture Anchor | K113299 |
| Additional Predicates: | ||
| Arthrex, Inc. | Arthrex 3.0mm SutureTak | K061863 |
| RoG Sports Medicine Inc. | Rog Suture Anchor 5.5mm, 2.9mm | K110229 |
| RoG Sports Medicine Inc. | Rog Knotless Suture Anchor | K110230 |
| RoG Sports Medicine Inc. | Rog Suture Anchor, Rog Knotless Suture | |
| Anchor | K111590 | |
| RoG Sports Medicine Inc. | Modified Rog Suture Anchor | K112991 |
Device Description
The Flower Suture Anchor Set consists of FlowerAnchor, 3.0mm, FlowerAnchor, 5.0mm, and FlowerAnchor, Knotless with lengths of 10mm and 17mm, respectively. The anchors are screw-like in shape and made of PEEK. The anchors are threaded with ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures. The 3.0mm and 5.0mm anchors, USP Size 0 and Size 2 sutures, and inserters and the Knotless anchor and inserter are supplied as a single assembly, sterilized by ethylene-oxide, nonpyrogenic, and ready-for-surgery.
5
Accessories of Taps and Drill Bit Kits are supplied sterile by means of gamma radiation with the Flower Suture Anchor Set.
Intended Use / Indications for Use
The Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease,
The FlowerAnchor, 3.0mm is indicated for use in soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
- Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis,
- Wrist/hand indications: Scapholunate ligament reconstruction.
- · Foot/Ankle indications: Tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- · Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
- Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The FlowerAnchor, 5.0mm and FlowerAnchor, Knotless is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
- Shoulder indications: Bankart repair, rotator cuff repair, SLAP lesion repair,capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
- Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
- · Foot/Ankle indications: Achilles tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
- · Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
- Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
6
| Device | Subject Device
Flower Suture
Anchor Set | Primary Predicate
Rog Suture
Anchor | Arthrex 3.0mm
SutureTak | Rog Suture Anchor
5.5mm, 2.9mm | Rog Knotless
Suture Anchor | Rog Suture Anchor,
Rog Knotless Suture
Anchor | Modified Rog Suture
Anchor |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)# | K192949 | K113299 | K061863 | K110229 | K110230 | K111590 | K112991 |
| Intended Use | Secure soft tissue to
bone | Secure soft tissue to
bone | Secure soft tissue
to bone | Secure soft tissue
to bone | Secure soft tissue to
bone | Secure soft tissue to
bone | Secure soft tissue to
bone |
| Indications for
Use | The FlowerAnchor,
5.0mm and
FlowerAnchor,
Knotless is indicated
for soft tissue
reattachment
procedures in the
shoulder, elbow,
wrist/hand,
foot/ankle and knee.
Specific indications
are as follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion
repair, capsule repair
or capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Ulnar/Radial
collateral ligament
reconstruction,
scapholunate
ligament
reconstruction.
Foot/Ankle
indications: | The RoGTM 5.5 mm
Suture Anchor is
indicated for soft
tissue reattachment
procedures in the
shoulder, elbow,
wrist/hand,
foot/ankle and knee.
Specific indications
are as follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion repair,
capsule repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Ulnar/Radial
collateral ligament
reconstruction,
scapholunate
ligament
reconstruction.
Foot/ankle
indications:
Achilles tendon
repair/reconstruction
, hallax valgus
reconstruction,
lateral stabilization,
medial stabilizati | The Arthrex
Corkscrew Family
of Suture Anchors
has been
previously cleared
in 510(k) K003817,
K003227,
K043337, and
K050358. These
suture anchors are
intended for
fixation of
suture(soft tissue)
to bone in the
shoulder,
foot/ankle, hip,
knee, hand/wrist,
elbow, and pelvis
in, but not limited
to, the following
procedures:
Shoulder: Rotator
Cuff Repairs,
Bankart Repair,
SLAP Lesion
Repair, Biceps
Tenodesis,
Acromio-Clavicular
Separation Repair,
Deltoid Repair,
Capsular Shift or
Capsulolabral
Reconstruction.
Foot/Ankle:
Lateral
Stabilization,
Medial
Stabilization | The RoG 5.5 mm
Suture Anchor is
indicated for soft
tissue
reattachment
procedures in the
shoulder, elbow,
wrist/hand,
foot/ankle and
knee. Specific
indications are as
follows: Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion
repair, capsule
repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Ulnar/Radial
collateral ligament
reconstruction,
scapholunate
ligament
reconstruction.
Foot/Ankle
indications:
Achilles tendon
repair/reconstructi
on, hallax valgus
atruatio | The RoG 5.5mm
Knotless Suture
Anchor is indicated
for soft tissue
reattachment
procedures in the
shoulder, elbow,
wrist/hand,
foottankle and knee.
Specific indications
are as follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion repair,
capsule repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis-
Wrist/Hand
indications:
Ulnar/Radial
collateral ligament
reconstruction,
scapholunate
ligament
reconstruction.
Foot/Ankle
indications:
Achilles tendon
repair/reconstruction
, hallax valgus
reconstruction,
Lateral stabilizati | The RoG 5.5 mm
Suture Anchor is
indicated for soft
tissue reattachment
procedures in the
shoulder, elbow,
wrist/hand,
foot/ankle and knee.
Specific indications
are as follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion repair,
capsule repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Ulnar/Radial
collateral ligament
reconstruction,
scapholunate
ligament
reconstruction.
Foot/Ankle
indications:
Achilles tendon
repair/reconstruction
, hallax valgus
reconstruction,
lateral stabilization, | The RoG 5.5 mm
Suture Anchor is
indicated for soft
tissue reattachment
procedures in the
shoulder, elbow,
wrist/hand,
foot/ankle and knee
Specific indications
are as follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion repair,
capsule repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Ulnar/Radial
collateral ligament
reconstruction,
scapholunate
ligament
reconstruction.
Foot/Ankle
indications:
Achilles tendon
repair/reconstructio
, hallax valgus
reconstruction,
lateral stabilization,
modial otobilization |
| , hallux valgus
reconstruction,
lateral stabilization,
medial stabilization,
mid- and forefoot
reconstructions. | reconstructions.
Elbow indications:
Biceps tendon
reconstruction, ulnar
or radial collateral
ligament
reconstruction,
lateral epicondylitis
repair.
Knee indications:
Lateral collateral
ligament repair,
medial collateral
ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair, iliotibial band
tenodesis, joint
capsule closure. | Repair, Hallux
Valgus
Reconstruction,
Midfoot
Reconstruction,
Metatarsal
Ligament [Tendon
Repair],
Bunionectomy.
Knee: Anterior
Cruciate Ligament
Repair, Medial
Collateral
Ligament Repair,
Lateral Collateral
Ligament Repair,
Patellar Tendon
Repair, Posterior
Oblique Ligament
Repair, and
Iliotibial Band
Tenodesis.
Hand/Wrist:
Scapholunate
Ligament
Reconstruction,
Ulnar Collateral
Ligament
Reconstruction,
Radial Collateral
Ligament
Reconstruction.
Elbow: Biceps
Tendon
Reattachment,
Tennis Elbow
Repair, Ulnar or
Radial Collateral
Ligament
Reconstruction,
Lateral
Epicondylitis
repair. Pelvis:
Bladder Neck
Suspension for
female urinary
incontinence due
to urethral
hypermobility of
intrinsic sphincter | stabilization,
medial
stabilization, mid-
and forefoot
reconstructions.
Elbow
indications:
Biceps tendon
reconstruction,
ulnar or radial
collateral ligament
reconstruction,
lateral
epicondylitis
repair.
Knee indications:
Lateral collateral
ligament repair,
medial collateral
ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair. Iliotibial
band tenodesis,
joint capsule
closure. | mid- and forefoot
reconstructions.
Elbow indications:
Biceps tendon
reconstruction, ulnar
or radial collateral
ligament
reconstruction,
lateral epicondylitis
repair.
Knee indications:
Lateral collateral
ligament repair,
medial collateral
ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair. Iliotibial band
tenodesis, joint
capsule closure. | reconstructions.
Elbow indications:
Biceps tendon
reconstruction, ulnar
or radial collateral
ligament
reconstruction,
lateral epicondylitis
repair.
Knee indications:
Lateral collateral
ligament repair,
medial collateral
ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair. Iliotibial
band tenodesis,
joint capsule
closure. | reconstructions.
Elbow indications:
Biceps tendon
reconstruction, ulnar
or radial collateral
ligament
reconstruction,
lateral epicondylitis
repair.
Knee indications:
Lateral collateral
ligament repair,
medial collateral
ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair. Iliotibial band
tenodesis, joint
capsule closure.
The RoG 2.9mm
Suture Anchor is
indicated for use in
soft tissue
reattachment
procedures. Specific
indications are as
follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion repair,
capsule repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Scapholunate
ligament
reconstruction.
Elbow indications:
Biceps tendon
reconstruction ulnar | |
| The FlowerAnchor,
3.0mm is indicated
for use in soft tissue
reattachment
procedures in the
shoulder, elbow,
wrist/hand,
foot/ankle and knee.
Specific indications
are as follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion repair,
capsule repair or
capsulolabral
reconstruction, | The RoGTM 2.9mm
Suture Anchor is
indicated for use in
soft tissue
reattachment
procedures. Specific
indications are as
follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion repair,
capsule repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Scapholunate
ligament
reconstruction.
Elbow indications:
Biceps tendon
reconstruction ulnar | The RoG 2.9mm
Suture Anchor is
indicated for use
in soft tissue
reattachment
procedures.
Specific
indications are as
follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion
repair, capsule
repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair biceps | The RoG 2.9mm
Suture Anchor is
indicated for use in
soft tissue
reattachment
procedures. Specific
indications are as
follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion repair,
capsule repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Scapholunate
ligament
reconstruction.
Elbow indications:
Biceps tendon | The RoG 2.9mm
Suture Anchor is
indicated for use in
soft tissue
reattachment
procedures. Specific
indications are as
follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion repair,
capsule repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Scapholunate
ligament
reconstruction.
Elbow indications:
Biceps tendon
reconstruction ulnar | | | |
7
8
| acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Scapholunate
ligament
reconstruction.
Foot/Ankle
indications:
Tendon
repair/reconstruction
, hallux valgus
reconstruction,
lateral stabilization,
medial stabilization,
mid- and forefoot
reconstructions.
Elbow indications:
Biceps tendon
reconstruction, ulnar
or radial collateral
ligament
reconstruction.
Knee indications:
Lateral collateral
ligament repair,
medial collateral
ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair, iliotibial band
tenodesis, joint
capsule closure,
extracapsular repair,
vastus medialis
obliquus (VMO)
muscle
advancement. | or radial collateral
ligament
reconstruction.
Knee indications:
Lateral collateral
ligament repair,
medial collateral
ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair, iliotibial band
tenodesis, joint
capsule closure,
extracapsular repair,
vastus medialis
obliquus (VMO)
muscle
advancement.
The RoGTM 5.5 mm
Knotless Suture
Anchor is indicated
for soft tissue
reattachment
procedures in the
shoulder, elbow,
wrist/hand,
foot/ankle and knee.
Specific indications
are as follows:
Shoulder
indications:
Bankart repair,
rotator cuff repair,
SLAP lesion repair,
capsule repair or
capsulolabral
reconstruction,
acromio-clavicular
separation, deltoid
repair, biceps
tenodesis.
Wrist/hand
indications:
Ulnar/Radial
collateral ligament
reconstruction,
scapholunate | deficiency. Hip:
Capsular repair,
acetabular labral
repair. | tenodesis.
Wrist/hand
indications:
Scapholunate
ligament
reconstruction.
Elbow
indications:
Biceps tendon
reconstruction,
ulnar or radial
collateral ligament
reconstruction.
Knee indications:
Lateral collateral
ligament repair,
medial collateral
ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair. Iliotibial
band tenodesis,
joint capsule
closure.
Extracapsular
repair, vastus
medialis obliquus
(VMO) muscle
advancement. | reconstruction, ulnar
or radial collateral
ligament
reconstruction.
Knee indications:
Lateral collateral
ligament repair,
medial collateral
ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair. Iliotibial band
tenodesis, joint
capsule closure.
Extracapsular repair,
vastus medialis
obliquus (VMO)
muscle
advancement. | or radial collateral
ligament
reconstruction.
Knee indications:
Lateral collateral
ligament repair,
medial collateral
ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair. Iliotibial band
tenodesis, joint
capsule closure.
Extracapsular repair
vastus medialis
obliquus (VMO)
muscle
advancement. |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
9
| Classification
Name | Fastener, Fixation,
Nondegradable,
Soft Tissue | Fastener, Fixation,
Nondegradable,
Soft Tissue | Screw, Fixation,
Bone | Fastener, Fixation,
Nondegradable,
Soft Tissue | Fastener, Fixation,
Nondegradable,
Soft Tissue | Fastener, Fixation,
Nondegradable, Soft
Tissue | Fastener, Fixation,
Nondegradable, Soft
Tissue |
|------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| | | ligament
reconstruction.
Foot/ankle
indications:
Achilles tendon
repair/reconstruction
, hallax valgus
reconstruction,
lateral stabilization,
medial stabilization,
mid- and forefoot | | | | | |
| | | reconstructions.
Elbow indications:
Biceps tendon
reconstruction, ulnar
or radial collateral
ligament
reconstruction,
lateral epicondylitis
repair.
Knee indications:
Lateral collateral
ligament repair,
medial collateral | | | | | |
| | | ligament repair,
posterior oblique
ligament repair,
patellar
ligament/tendon
repair, iliotibial band
tenodesis, joint
capsule closure. | | | | | |
| Product Code | MBI | MBI | HWC
(JDR, MAI, MBI) | MBI | MBI | MBI | MBI |
| Material | PEEK | PEEK | PEEK | PEEK | PEEK | PEEK | PEEK |
| Sizes | 3.0mm, 5.0mm | 5.5mm, 2.9mm | 3.0mm | 5.5mm, 2.9mm | 5.5mm | 5.5mm, 2.9mm | 5.5mm, 2.9mm |
10
Comparison of Technological Characteristics
Soft tissue reattachment aid using PEEK anchors and non-absorbable suture is the technological principle for both the subject and predicate devices. It is based on the use of one or more PEEK anchors with non-absorbable sutures. At a high level, the subject and predicate devices have the same indication for use and are made from the same materials. The suture is from the same supplier as the primary predicate. Anchors are both made from PEEK. Additionally, both the subject and predicate devices are provided sterile.
There are several technological differences between the subject and predicate devices. The primary predicate device offers a 2.9mm and 5.5mm diameter anchor while Flower Orthopedics Suture Anchor Set offers a 3.0mm and 5.0mm diameter anchor. Thus, the proposed diameters for the Flower Orthopedics Suture Anchor Set is within the range of the predicate devices. Although there are minor differences in dimensions and design, testing of the subject device establishes equivalent mechanical strength of the subject device as compared to the predicate device. The primary predicate device offers a single strand of USP size 2 suture with their 2.9mm anchor while the FlowerAnchor 3.0mm offers two strands of USP size 0 sutures. The sutures have been previously cleared.
Performance Data
The Flower Suture Anchor Set was tested (worse case) in accordance with FDA's Draft Guidance Document for Testing Bone Anchor Devices. Testing consisted of Insertion, Pull out, and Fatigue in comparison to the predicate devices. The subject device was found to be equivalent to the predicate devices in such performance. Cytotoxicity testing was also separately performed on both the patientcontacting and non-patient-contacting components
Additionally, the Flower Suture Anchor Set was evaluated according to the following standards:
- USP 41-NF36:2018 , Sutures Diameter .
- USP 41-NF36:2018 , Sutures Needle Attachment ●
- USP 41-NF36:2018 , Tensile Strength .
- ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process;
- ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity:
- ISO 10993-7, Ethylene oxide sterilization residuals .
- ISO 11135-1, Ethylene Oxide Sterilization .
- ISO 11137, Radiation Sterilization ●
- ANSI/AAMI ST72:2011/ (R)2016, Bacterial Endotoxins Test Methods, Routine ● Monitoring, And Alternatives To Batch Testing
In all instances, the Flower Suture Anchor Set functioned and test results demonstrated substantial equivalence with the cited predicate devices.
11
Conclusions
The Flower Suture Anchor Set is as safe and effective as the identified predicate devices. The subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in the device configuration being packaged with additional sutures and inserters raise no new issues of safety or effectiveness Performance data demonstrate that the subject devices are as safe and effective as the predicate devices. Thus, the Flower Suture Anchor Set is substantially equivalent.