PEBA ANCHOR/SUTURE COMBINATION

• K Number: K972326
• Device Name: PEBA ANCHOR/SUTURE COMBINATION
• Manufacturer: ORTHOPAEDIC BIOSYSTEMS, LTD.
• Date Cleared: 1998-02-06 ( 228 days)
• Product Code: MBI JDR
• Regulation Number: 888.3040

Intended Use

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures. The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications: Shoulder: 1. Bankart lesion repairs 2. SLAP lesion repairs 3. Acromio-clavicular separation repairs 4. Rotator cuff tear repairs 5. Capsular shift or capsulolabral reconstructions 6. Biceps tenodesis 7. Deltoid repairs Foot and Ankle: 1. Hallux Valgus repairs 2. Medial or lateral instability repairs/reconstructions 3. Achilles tendon repairs/reconstructions 4. Midfoot reconstructions 5. Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand: 1. Scapholunate ligament reconstructions 2. Ulnar or radial collateral ligament reconstructions 3. Tennis elbow repair 4. Biceps tendon reattachment Knee: 1. Extra-capsular repairs: a. medial collateral ligament b. lateral collateral ligament c. posterior oblique ligament 2. Iliotiband tenodesis 3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

Device Description

The proposed device, Anchor/Suture Combination is a pre-packaged, sterile device composed of a suture anchor, anchor inserter, and non-absorbable sutures. The device shall be used to secure soft tissue to bone. The device is pre-packaged so that the suture is looped through the anchor eyelet and the anchor/suture is installed in the inserter. The anchor implant site shall be prepared with an appropriate OBL drill. The inserter is used to screw the anchor into the implant site. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and suture looped through the anchor. The proposed device is constructed from the following materials. The anchor is made of titanium alloy TI6Al4VELI. The suture is multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture meeting USP requirements. The inserter shaft is a 300 series, 400 series, 17Cr-4Ni, or other alloy stainless steel.

Predicate Devices

K951451

Reference Devices

N80950

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are purely mechanical, describing a suture anchor and inserter for fixing sutures to bone. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.

Therapeutic

Yes
The device is intended for the fixation of sutures for various repairs and reconstructions of soft tissue, directly addressing medical conditions and restoring bodily function.

Diagnostic

No
The device is used for the fixation of sutures in reconstructive surgeries, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a pre-packaged, sterile device composed of a suture anchor, anchor inserter, and non-absorbable sutures, which are physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
• Device Description: The description clearly states that this device is an "Anchor/Suture Combination" used to "secure soft tissue to bone." It is an implantable device used during surgical procedures.
• Intended Use: The intended use is for the "fixation of non-absorbable synthetic sutures" for various surgical repairs in different anatomical locations. This is a surgical fixation device, not a diagnostic test performed on a specimen.

The device is a surgical implant and associated tools, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.

The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphinctor deficiency.

The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:

Shoulder:

1. Bankart lesion repairs
2. SLAP lesion repairs
3. Acromio-clavicular separation repairs
4. Rotator cuff tear repairs
5. Capsular shift or capsulolabral reconstructions
6. Biceps tenodesis
7. Deltoid repairs

Foot and Ankle:

1. Hallux Valgus repairs
2. Medial or lateral instability repairs/reconstructions
3. Achilles tendon repairs/reconstructions
4. Midfoot reconstructions
5. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

1. Scapholunate ligament reconstructions
2. Ulnar or radial collateral ligament reconstructions
3. Tennis elbow repair
4. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs:
   a. medial collateral ligament
   b. lateral collateral ligament
   c. posterior oblique ligament
2. Iliotibial band tenodesis
3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

Product codes (comma separated list FDA assigned to the subject device)

JDR, MBI

Device Description

The proposed device, Anchor/Suture Combination is a pre-packaged, sterile device composed of a suture anchor, anchor inserter, and non-absorbable sutures. The device shall be used to secure soft tissue to bone. The device is pre-packaged so that the suture is looped through the anchor eyelet and the anchor/suture is installed in the inserter. The anchor implant site shall be prepared with an appropriate OBL drill. The inserter is used to screw the anchor into the implant site. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and suture looped through the anchor.

The suture used in the proposed device is a braided polyester suture provided by Surgical Specialties and is currently market through N80950.

The scientific basis for the device includes that the anchor is constructed as a screw with a means for suture to be secured to the thread body. When the threads are fully seated and the suture is secured to soft tissue, the anchor and suture shall be in tension to hold the soft tissue to the bone.

The proposed device is constructed from the following materials. The anchor is made of titanium alloy TI6Al4VELI. The suture is multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture meeting USP requirements. The inserter shaft is a 300 series, 400 series, 17Cr-4Ni, or other alloy stainless steel.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pelvis, Shoulder, Foot and Ankle, Elbow, Wrist, Hand, 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)

Not Found

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.

K951451

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.

N80950

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

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.

Summary

0

K972326

510 (k) SUMMARY - SAFETY and EFFECTIVENESS

Submitted by: Jeffrey P. Baldwin Orthopaedic Biosystems Limited, Incorporated 15990 N. Greenway-Hayden Loop, Suite 100 Scottsdale, AZ 85260 Phone: [phone]

Contact: Jeffry B. Skiba, Vice President of Engineering & Manufacturing

Date of preparation: October 1, 1997

Name: Anchor/Suture Combination Proprietary Name: PeBA Anchor/Suture Combination, Cinch Anchor/Suture Combination Common or usual name: Anchor/Suture Combination Regulatory Class: Class II

Since this submission deals with suture anchor of varying size, each size must be compared to legally marketed devices of reasonably equivalent size. See table on page 2 of this packet.

១/១០០/អម០១

6 1998

FEB

Proposed Device	Equivalent Device
PeBA S 2.8 mm Anchor	Zimmer's Statak 2.5
PeBA C 4.0 mm Anchor	Arthrex's Corkscrew 5.0
PeBA RCR 5.0 mm Anchor*	Arthrex's Corkscrew 5.0
PeBA C 6.8 mm Anchor	Arthrex's Corkscrew 5.0

The proposed device, Anchor/Suture Combination is a pre-packaged, sterile device composed of a suture anchor, anchor inserter, and non-absorbable sutures. The device shall be used to secure soft tissue to bone. The device is pre-packaged so that the suture is looped through the anchor eyelet and the anchor/suture is installed in the inserter. The anchor implant site shall be prepared with an appropriate OBL drill. The inserter is used to screw the anchor into the implant site. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and suture looped through the anchor.

All OBL anchors are marketed through K951451. The proposed device uses these 510K approved anchors and has identical Indications For Use as the S10K approved anchors.

The suture used in the proposed device is a braided polyester suture provided by Surgical Specialties and is currently market through N80950.

1

The scientific basis for the device includes that the anchor is constructed as a screw with a means for suture to be secured to the thread body. When the threads are fully seated and the suture is secured to soft tissue, the anchor and suture shall be in tension to hold the soft tissue to the bone.

The proposed device is constructed from the following materials. The anchor is made of titanium alloy TI6Al4VELI. The suture is multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture meeting USP requirements. The inserter shaft is a 300 series, 400 series, 17Cr-4Ni, or other alloy stainless steel.

Please find the two attached "Package Inserts." OBL's anchors are marketed two ways. anchors for bladder neck suspension procedures, and anchors for orthopaedic uses other than bladder neck suspension procedures. The anchors marketed for bladder neck suspension procedures are sold under the name, Cinch™. The anchors that are marketed for orthopaedic procedures other than bladder neck suspension procedures are sold under the name, PeBA Series. Likewise, the anchor/suture combination will be sold as separate devices: The Cinch™ anchor/suture combination for bladder neck suspensions and the PeBA anchor/suture combination for the following indications:

Indications For Use:

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.

The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphinctor deficiency.

The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:

Shoulder:

• 1. Bankart lesion repairs
• 2. SLAP lesion repairs
• 3. Acromio-clavicular separation repairs
• 4. Rotator cuff tear repairs
• 5. Capsular shift or capsulolabral reconstructions
• 6. Biceps tenodesis
• 7. Deltoid repairs

Foot and Ankle:

• 1. Hallux Valgus repairs
• 2. Medial or lateral instability repairs/reconstructions
• 3. Achilles tendon repairs/reconstructions
• 4. Midfoot reconstructions
• 5. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

• 1. Scapholunate ligament reconstructions
     pp

2

• 2. Ulnar or radial collateral ligament reconstructions in
• 3. Tennis elbow repair
• 3. Tennis cloow repair.

4. Biceps tendon reattachment

Knee:

res m

• 1. Extra-capsular repairs:
  • medial collateral ligament a.
  • lateral collateral ligament b.
  • posterior oblique ligament C.
• 2. Iliotibial band tenodesis
• 2. Iliotibial band tenodesis

3. Patellar realignment and tendon repairs, including vastus medialis obliquous
   • advancement

Following are tables of comparison and contrass between the PeBA Anchors and the f
or and the mail and institution table on page 2 of this packet. Following are tables of Companses and con page 2 of this packet.

	PeBA S 2.8 mm Anchor	Zimmer Statak 2.5 Anchor
Characteristic
Anchor material	Titanium	Titanium
Inserter material	Stainless Steel	Stainless Steel
Suture material	Braided Polyester	Braided Polyester
Method of insertion	Inserter/anchor interface
hexagonal. Inserter turned
to screw anchor into bone.	Inserter/anchor interface
hexagonal. Inserter turned to
screw anchor into bone.
Basic construction of
inserter	A hardened stainless steel
shaft contains the
hexagonal receptacle for
the anchor head. The
shaft is cannulated to
contain the suture.	A hardened stainless steel tip
is fit into the shaft. The tip
contains the hexagonal
receptacle for the anchor
head. The tip and shaft are
cannulated to contain the
suture.

	BA S 2.8 mm Anchor compared to the Zimmer Statak 2.5
--	------------------------------------------------------	--

	D-BA S 2 8 mm Anchor contrasted to the Zimmer Statak 2.5
			and the program of the program of the program and to finance of the first of the first of the first of the first of the first of the first of the first of the first of the fi

Characteristic	PeBA S 2.8 mm Anchor	Zimmer Statak 2.5 Anchor
Number of included sutures	1 or 2	1
Size of included suture	USP #2, #1, #0, #2-0	USP #0
Thread design	Double lead (“Hi-Lo” thread design). No drill means.	Single lead with a drill means.
Thread diameter	2.8 mm	2.5 mm

3

| Characteristic | PeBA C 4.0 mm Anchor compared to the Arthrex Corkscrew
PeBA C 4.0 mm Anchor | Arthrex Corkscrew 5.0 mm
Anchor |
|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anchor material
Inserter material
Suture material
Method of insertion
Basic construction of
inserter | Titanium
Stainless Steel
Braided Polyester
Inserter/anchor interface
hexagonal. Inserter turned
to screw anchor into bone.
A hardened stainless steel
shaft contains the
hexagonal receptacle for
the anchor head. The
shaft is cannulated to
contain the suture. | Titanium
Stainless Steel
Braided Polyester
Inserter/anchor interface
hexagonal. Inserter turned to
screw anchor into bone.
A hardened stainless steel
shaft contains the hexagonal
receptacle for the anchor
head. The shaft is cannulated
to contain the suture. |

ared to the Arthrex Corkscrew 5.0 mm

.

:

.

:

:

:

ر

PeBA C 4.0 mm Anchor contrasted to the Arthrex Corkscrew 5.0 mm

. . . . . . . .

: .

.

PeBA C 4.0 mm Anchor contrasted to the Arthrex Corkscrew 5.0 mm
Characteristic	PeBA C 4.0 mm Anchor	Arthrex Corkscrew 5.0 mm Anchor
Number of included sutures	1 or 2	2
Size of included suture	USP #5, #2, #1, #0	USP #2
Thread design	Double lead (“Hi-Lo” thread design) No drill means.	Single lead with a drill means.
Thread diameter	2.8 mm	2.5 mm

---

:

4

. . . . . . .

.

4

Characteristic	PeBA C 6.5 mm Anchor	Arthrex Corkscrew 5.0 mm Anchor
Anchor material	Titanium	Titanium
Inserter material	Stainless Steel	Stainless Steel
Suture material	Braided Polyester	Braided Polyester
Method of insertion	Inserter/anchor interface
hexagonal. Inserter turned
to screw anchor into bone.	Inserter/anchor interface
hexagonal. Inserter turned to
screw anchor into bone.
Basic construction of
inserter	A hardened stainless steel
shaft contains the
hexagonal receptacle for
the anchor head. The
shaft is cannulated to
contain the suture.	A hardened stainless steel
shaft contains the hexagonal
receptacle for the anchor
head. The shaft is cannulated
to contain the suture.

..

. .

:

.

: ،

.

.

ists the Arthrex Corkscrew 5.0 mm

BA C 6.5 mm Anchor contrasted to the Arthrex Corkscrew 5.0 mm

!

.

ﻧ

:

1

Characteristic	PeBA C 6.5 mm Anchor	Arthrex Corkscrew 5.0 mm Anchor
Number of included sutures	1 or 2	2
Size of included suture	USP #5, #2, #1, #0	USP #2
Thread design	Double lead (“Hi-Lo” thread design) No drill means.	Single lead with a drill means.
Thread diameter	2.8 mm	2.5 mm

.

:

:

5

Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the head, body, and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 1998

Mr. Jeffrey B. Skiba ·Vice President of Engineering Orthopaedic Biosystems Limited, Inc. 7320 East Butherus, Suite 206 85260 Scottsdale, Arizona

Re: K972326 PeBA Anchor/Suture Combination Requlatory Class: II Product Codes: JDR and MBI Dated: January 6, 1998 Received: January 9, 1998

Dear Mr. Skiba:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with _____ the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

6

Page 2 - Mr. Jeffrey B. Skiba

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

Cellia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Appendix D: Indications for Use

510(k) Number (if known): K972326

vice Name: PEBA ANCHOR SUTURE COMBINATION

Indications For Use:

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.

The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female unnary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The PeBA Series Anchor/Sulure Combination is intended for the fixation of surgical suture material for the following indications:

Shoulder: 1. Bankart lesion repairs SLAP lesion repairs 2. /300/H803/ Acromio-clavicular separation repairs 3. 4. Rotator cuff tear repairs ર. Capsular shift or capsulolabral reconstructions 6. Biceps tenodesis 7. Deltoid repairs Foot and Ankle: Hallux Valgus repairs 1. Medial or lateral instability repairs/reconstructions 2. Achilles tendon repairs/reconstructions 3. 4. Midfoot reconstructions 5. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

• 1. Scapholunate ligament reconstructions
• 2. Ulnar or radial collateral ligament reconstructions
• Tennis elbow repair 3.
• 4. Biceps tendon reattachment

Knee:

• 1. Extra-capsular repairs:
  • a. medial collateral ligament
  • lateral collateral ligament b.
  • posterior oblique ligament C.
• 2. Iliotibial band tenodesis
• 3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OI

A co
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K472326

Prescription Use: Y 21 CFR 801.109)

OR

Over-The-Counter Use:

(Optional Format 1-2-96)