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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Flower Suture Anchor Set." It does not present a study proving the device meets acceptance criteria in the context of an AI/ML-driven solution or diagnostic tool. Instead, it demonstrates substantial equivalence to existing predicate devices based on mechanical and biological performance testing for hardware.

Here's why the requested information about AI model acceptance criteria and study data cannot be provided from this document:

Device Type: The "Flower Suture Anchor Set" is a physical orthopedic surgical device (suture anchors made of PEEK for soft tissue reattachment). It is not an AI/ML diagnostic tool, an image analysis algorithm, or any software-based medical device.
Regulatory Pathway: The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering testing, material compatibility, and comparison of physical characteristics and intended use. It does not typically involve clinical studies with human readers or AI performance metrics.
Performance Data Section: The "Performance Data" section describes mechanical testing (insertion, pull-out, fatigue), biocompatibility testing (cytotoxicity), and adherence to sterilization standards for the physical device. These are standard engineering tests for implants and surgical tools, not AI model validation.

Therefore, since the document pertains to a physical medical device and not an AI/ML system, the following requested information cannot be extracted or inferred:

A table of acceptance criteria and the reported device performance: The acceptance criteria relate to mechanical strength, biocompatibility, and sterilization for a surgical anchor, not diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) typically associated with AI.
Sample size used for the test set and the data provenance: Not applicable to AI testing. The "test set" here refers to physical samples of the suture anchors subjected to mechanical and biological tests.
Number of experts used to establish the ground truth...: Not applicable. Ground truth for a physical device is established through engineering and laboratory measurements, not expert consensus on images.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable as there are no "human readers" involved in the performance of a suture anchor.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device performs a mechanical function.
The type of ground truth used: For a physical device, ground truth is based on physical measurements and material standards.
The sample size for the training set: Not applicable. This is a manufactured product, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, this document is entirely outside the scope of AI/ML medical device regulation and testing. It provides information relevant to the substantial equivalence of a physical surgical implant, not the acceptance criteria or performance studies of an AI model.

Summary

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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

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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

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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.

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.

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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 SutureAnchor	K111590
RoG Sports Medicine Inc.	Modified Rog Suture Anchor	K112991

Device Description

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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.

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Device	Subject DeviceFlower SutureAnchor Set	Primary PredicateRog SutureAnchor	Arthrex 3.0mmSutureTak	Rog Suture Anchor5.5mm, 2.9mm	Rog KnotlessSuture Anchor	Rog Suture Anchor,Rog Knotless SutureAnchor	Modified Rog SutureAnchor
510(k)#	K192949	K113299	K061863	K110229	K110230	K111590	K112991
Intended Use	Secure soft tissue tobone	Secure soft tissue tobone	Secure soft tissueto bone	Secure soft tissueto bone	Secure soft tissue tobone	Secure soft tissue tobone	Secure soft tissue tobone
Indications forUse	The FlowerAnchor,5.0mm andFlowerAnchor,Knotless is indicatedfor soft tissuereattachmentprocedures in theshoulder, elbow,wrist/hand,foot/ankle and knee.Specific indicationsare as follows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesionrepair, capsule repairor capsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Ulnar/Radialcollateral ligamentreconstruction,scapholunateligamentreconstruction.Foot/Ankleindications:	The RoGTM 5.5 mmSuture Anchor isindicated for softtissue reattachmentprocedures in theshoulder, elbow,wrist/hand,foot/ankle and knee.Specific indicationsare as follows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesion repair,capsule repair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Ulnar/Radialcollateral ligamentreconstruction,scapholunateligamentreconstruction.Foot/ankleindications:Achilles tendonrepair/reconstruction, hallax valgusreconstruction,lateral stabilization,medial stabilizati	The ArthrexCorkscrew Familyof Suture Anchorshas beenpreviously clearedin 510(k) K003817,K003227,K043337, andK050358. Thesesuture anchors areintended forfixation ofsuture(soft tissue)to bone in theshoulder,foot/ankle, hip,knee, hand/wrist,elbow, and pelvisin, but not limitedto, the followingprocedures:Shoulder: RotatorCuff Repairs,Bankart Repair,SLAP LesionRepair, BicepsTenodesis,Acromio-ClavicularSeparation Repair,Deltoid Repair,Capsular Shift orCapsulolabralReconstruction.Foot/Ankle:LateralStabilization,MedialStabilization	The RoG 5.5 mmSuture Anchor isindicated for softtissuereattachmentprocedures in theshoulder, elbow,wrist/hand,foot/ankle andknee. Specificindications are asfollows: Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesionrepair, capsulerepair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Ulnar/Radialcollateral ligamentreconstruction,scapholunateligamentreconstruction.Foot/Ankleindications:Achilles tendonrepair/reconstruction, hallax valgusatruatio	The RoG 5.5mmKnotless SutureAnchor is indicatedfor soft tissuereattachmentprocedures in theshoulder, elbow,wrist/hand,foottankle and knee.Specific indicationsare as follows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesion repair,capsule repair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis-Wrist/Handindications:Ulnar/Radialcollateral ligamentreconstruction,scapholunateligamentreconstruction.Foot/Ankleindications:Achilles tendonrepair/reconstruction, hallax valgusreconstruction,Lateral stabilizati	The RoG 5.5 mmSuture Anchor isindicated for softtissue reattachmentprocedures in theshoulder, elbow,wrist/hand,foot/ankle and knee.Specific indicationsare as follows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesion repair,capsule repair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Ulnar/Radialcollateral ligamentreconstruction,scapholunateligamentreconstruction.Foot/Ankleindications:Achilles tendonrepair/reconstruction, hallax valgusreconstruction,lateral stabilization,	The RoG 5.5 mmSuture Anchor isindicated for softtissue reattachmentprocedures in theshoulder, elbow,wrist/hand,foot/ankle and kneeSpecific indicationsare as follows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesion repair,capsule repair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Ulnar/Radialcollateral ligamentreconstruction,scapholunateligamentreconstruction.Foot/Ankleindications:Achilles tendonrepair/reconstructio, hallax valgusreconstruction,lateral stabilization,modial otobilization
, hallux valgusreconstruction,lateral stabilization,medial stabilization,mid- and forefootreconstructions.	reconstructions.Elbow indications:Biceps tendonreconstruction, ulnaror radial collateralligamentreconstruction,lateral epicondylitisrepair.Knee indications:Lateral collateralligament repair,medial collateralligament repair,posterior obliqueligament repair,patellarligament/tendonrepair, iliotibial bandtenodesis, jointcapsule closure.	Repair, HalluxValgusReconstruction,MidfootReconstruction,MetatarsalLigament [TendonRepair],Bunionectomy.Knee: AnteriorCruciate LigamentRepair, MedialCollateralLigament Repair,Lateral CollateralLigament Repair,Patellar TendonRepair, PosteriorOblique LigamentRepair, andIliotibial BandTenodesis.Hand/Wrist:ScapholunateLigamentReconstruction,Ulnar CollateralLigamentReconstruction,Radial CollateralLigamentReconstruction.Elbow: BicepsTendonReattachment,Tennis ElbowRepair, Ulnar orRadial CollateralLigamentReconstruction,LateralEpicondylitisrepair. Pelvis:Bladder NeckSuspension forfemale urinaryincontinence dueto urethralhypermobility ofintrinsic sphincter	stabilization,medialstabilization, mid-and forefootreconstructions.Elbowindications:Biceps tendonreconstruction,ulnar or radialcollateral ligamentreconstruction,lateralepicondylitisrepair.Knee indications:Lateral collateralligament repair,medial collateralligament repair,posterior obliqueligament repair,patellarligament/tendonrepair. Iliotibialband tenodesis,joint capsuleclosure.	mid- and forefootreconstructions.Elbow indications:Biceps tendonreconstruction, ulnaror radial collateralligamentreconstruction,lateral epicondylitisrepair.Knee indications:Lateral collateralligament repair,medial collateralligament repair,posterior obliqueligament repair,patellarligament/tendonrepair. Iliotibial bandtenodesis, jointcapsule closure.	reconstructions.Elbow indications:Biceps tendonreconstruction, ulnaror radial collateralligamentreconstruction,lateral epicondylitisrepair.Knee indications:Lateral collateralligament repair,medial collateralligament repair,posterior obliqueligament repair,patellarligament/tendonrepair. Iliotibialband tenodesis,joint capsuleclosure.	reconstructions.Elbow indications:Biceps tendonreconstruction, ulnaror radial collateralligamentreconstruction,lateral epicondylitisrepair.Knee indications:Lateral collateralligament repair,medial collateralligament repair,posterior obliqueligament repair,patellarligament/tendonrepair. Iliotibial bandtenodesis, jointcapsule closure.The RoG 2.9mmSuture Anchor isindicated for use insoft tissuereattachmentprocedures. Specificindications are asfollows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesion repair,capsule repair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Scapholunateligamentreconstruction.Elbow indications:Biceps tendonreconstruction ulnar
The FlowerAnchor,3.0mm is indicatedfor use in soft tissuereattachmentprocedures in theshoulder, elbow,wrist/hand,foot/ankle and knee.Specific indicationsare as follows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesion repair,capsule repair orcapsulolabralreconstruction,	The RoGTM 2.9mmSuture Anchor isindicated for use insoft tissuereattachmentprocedures. Specificindications are asfollows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesion repair,capsule repair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Scapholunateligamentreconstruction.Elbow indications:Biceps tendonreconstruction ulnar	The RoG 2.9mmSuture Anchor isindicated for usein soft tissuereattachmentprocedures.Specificindications are asfollows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesionrepair, capsulerepair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair biceps	The RoG 2.9mmSuture Anchor isindicated for use insoft tissuereattachmentprocedures. Specificindications are asfollows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesion repair,capsule repair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Scapholunateligamentreconstruction.Elbow indications:Biceps tendon	The RoG 2.9mmSuture Anchor isindicated for use insoft tissuereattachmentprocedures. Specificindications are asfollows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesion repair,capsule repair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Scapholunateligamentreconstruction.Elbow indications:Biceps tendonreconstruction ulnar

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acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Scapholunateligamentreconstruction.Foot/Ankleindications:Tendonrepair/reconstruction, hallux valgusreconstruction,lateral stabilization,medial stabilization,mid- and forefootreconstructions.Elbow indications:Biceps tendonreconstruction, ulnaror radial collateralligamentreconstruction.Knee indications:Lateral collateralligament repair,medial collateralligament repair,posterior obliqueligament repair,patellarligament/tendonrepair, iliotibial bandtenodesis, jointcapsule closure,extracapsular repair,vastus medialisobliquus (VMO)muscleadvancement.	or radial collateralligamentreconstruction.Knee indications:Lateral collateralligament repair,medial collateralligament repair,posterior obliqueligament repair,patellarligament/tendonrepair, iliotibial bandtenodesis, jointcapsule closure,extracapsular repair,vastus medialisobliquus (VMO)muscleadvancement.The RoGTM 5.5 mmKnotless SutureAnchor is indicatedfor soft tissuereattachmentprocedures in theshoulder, elbow,wrist/hand,foot/ankle and knee.Specific indicationsare as follows:Shoulderindications:Bankart repair,rotator cuff repair,SLAP lesion repair,capsule repair orcapsulolabralreconstruction,acromio-clavicularseparation, deltoidrepair, bicepstenodesis.Wrist/handindications:Ulnar/Radialcollateral ligamentreconstruction,scapholunate	deficiency. Hip:Capsular repair,acetabular labralrepair.	tenodesis.Wrist/handindications:Scapholunateligamentreconstruction.Elbowindications:Biceps tendonreconstruction,ulnar or radialcollateral ligamentreconstruction.Knee indications:Lateral collateralligament repair,medial collateralligament repair,posterior obliqueligament repair,patellarligament/tendonrepair. Iliotibialband tenodesis,joint capsuleclosure.Extracapsularrepair, vastusmedialis obliquus(VMO) muscleadvancement.	reconstruction, ulnaror radial collateralligamentreconstruction.Knee indications:Lateral collateralligament repair,medial collateralligament repair,posterior obliqueligament repair,patellarligament/tendonrepair. Iliotibial bandtenodesis, jointcapsule closure.Extracapsular repair,vastus medialisobliquus (VMO)muscleadvancement.	or radial collateralligamentreconstruction.Knee indications:Lateral collateralligament repair,medial collateralligament repair,posterior obliqueligament repair,patellarligament/tendonrepair. Iliotibial bandtenodesis, jointcapsule closure.Extracapsular repairvastus medialisobliquus (VMO)muscleadvancement.
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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ClassificationName	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, SoftTissue	Fastener, Fixation,Nondegradable, SoftTissue
		ligamentreconstruction.Foot/ankleindications:Achilles tendonrepair/reconstruction, hallax valgusreconstruction,lateral stabilization,medial stabilization,mid- and forefoot
		reconstructions.Elbow indications:Biceps tendonreconstruction, ulnaror radial collateralligamentreconstruction,lateral epicondylitisrepair.Knee indications:Lateral collateralligament repair,medial collateral
		ligament repair,posterior obliqueligament repair,patellarligament/tendonrepair, iliotibial bandtenodesis, jointcapsule 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

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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 <861>, Sutures Diameter .
USP 41-NF36:2018 <871>, Sutures Needle Attachment ●
USP 41-NF36:2018 <881>, 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.

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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.

Regulation Number and Section

§ 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.