K Number

Device Name

PHUSIS ABSORBABLE INTERFERENCE SCREW

Manufacturer

TORNIER

Date Cleared

1998-12-22

(656 days)

Product Code

HWC 87H MAI

Regulation Number

888.3040

Intended Use

Intended Use: 1. Interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. Specific Indications For Use: 1. Open Surgical Reconstruction of the Anterior Cruciate Ligament (ACL) 2. Arthroscopic ACL Reconstruction

Device Description

The device is a bioresorbable interference screw used for the anterior cruciate ligament (ACL). The Phusis® Absorbable Interference Screw system is made up of two different diameter screws (7.0mm and 9.0mm) available in two lengths for each diameter. The 7.0mm diameter screws are 20 & 25 mm in length and the 9.0mm screws are 25 & 30 mm in length. The thread profile is that of a non aggressive single lead thread (cancellous-type) with a pitch of approximately 12 to the inch. The thread is progressive in nature. That is, the distal end or tip of the screw is tapered slightly to improve ease of insertion. The cannulation channel serves two purposes, it allows for the insertion of a guide wirelpin and it provides the driver interface. The cannula channel is not round throughout its length, but rather, it is hex in configuration over most of its length. Only the last millimeter near the tip is round. This provides two specific benefits, maximum hex drive interface and excellent insertion when inserted over the guide pine/wire.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K933719, K895711

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and clinical outcomes of a bioresorbable interference screw, with no mention of AI or ML technology.

Therapeutic

Yes.
The device is used to fixate grafts in ACL reconstruction, which is a medical treatment.

Diagnostic

No
The device is described as an absorbable interference screw used for surgical fixation in ACL reconstruction, not for identifying the presence or absence of a disease or condition. Its purpose is therapeutic during surgery.

SaMD (Software as a Medical Device)

The device description clearly describes a physical, bioresorbable interference screw made of material, with specific dimensions and a thread profile, used for surgical fixation. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for the "Interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction." This is a surgical procedure performed directly on the patient's body.
Device Description: The device is a "bioresorbable interference screw" used to physically fix a graft during ACL reconstruction. This is a surgical implant.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
Anatomical Site: The device is used on the "Anterior Cruciate Ligament (ACL)," which is an anatomical structure within the body.
Intended User / Care Setting: The intended users are involved in "Surgical repair of the anterior cruciate ligament," which is a surgical procedure.

IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant for structural support.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

1. Surgical repair of the anterior cruciate ligament.
1. ACL repair.
1. Arthroscopic ACL repair.

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

87HWC, MAI

Device Description

The cannulation channel serves two purposes, it allows for the insertion of a guide wirelpin and it provides the driver interface. The cannula channel is not round throughout its length, but rather, it is hex in configuration over most of its length. Only the last millimeter near the tip is round. This provides two specific benefits, maximum hex drive interface and excellent insertion when inserted over the guide pine/wire.

Materials:
The material used to construct the device is described as an a -hydroxy-acid. Specifically, the material used in the construction of the Plusis® Absorbable Interference Screw is an exclusively lactic stereccopolymer containing PLA98 (98% L-lactic units and 2% D-lactic units. Resorption of PLA98 occurs exclusively by a chemical mechanism known as autocatalytic hydrolysis leading to progressive breaking of the macromolecular chains. The 2% of D-lactic units guarantee permanent hydrolysis of a PLA98 implant until its complete resorption.

Instrumentation:
Specialized instruments are provided as a part of the Phusis® Interference Screw system. There is a cannulated hex screw driver, a non-cannulated hex screw driver, a conformator (thread tap) a clearance template and a gauge. Guide wires of the appropriate diameter are also available with the system.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Anterior Cruciate Ligament (ACL), bone

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)

A retrospective review and analysis of European ACL reconstruction clinical results using the Phusis screw was undertaken. The purpose of the review was to examine clinical performance of the Phusis screw and contrast it with the Linvatec BioScrew and the Acufex metallic interference screw as reported in the peer review literature. Nine common ACL clinical variables were identified and matched for comparison. Appropriate statistical methodologies were applied.

The comprehensive report detailed variables such as n, average follow-up, symptoms, pivot shift, breakage of the screw on insertion, return to activity, intra-operative and post-operative complications, and final outcome was completed. The analysis supports the our conclusion that the performance of the Phusis screw is substantially equivalent to the referenced comparison 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.

K933719, K895711

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

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

Ka970829

(E) == (1) == (1) == (E) == (1) == ) == (A == ) == ) == ) == ) == ) == ) = ) = ) = ) = ) = ) = ) = ) = ) = ) = ) = = = ( = ) = = = ( = ) = = = ( = ) = = ) = = = = = = = = = =								.
			************************************************************************					. Комати да опечеравания каряского как в в в				.

			PETRE TEST PAT SALE SE S S S S S S F P L L F P L L C F F L F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F F







											Career of Children Annual Partify Party
		.
			Comment a marks and state and			al and for find a sm a li . "W class de
					. " we the state of the country of	100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000				.
	.		Caracter Products	.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------									Part P Bot Ca
						and and the manage of the first and the first








Control Can Can Car								. Sales of the state of the production of the comments of the states
A LIFe . In				------------------------------------------------------------------------------------------------------------------------------------------------------------------------------							.
			And see a status and the machines and the security of the start			.	A 47 . 141					.

:			.

Tornier S.A.

Phusis® Absorbable Interference Screw

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:
  Phusis® Absorbable Interference Screw Trade Name:

Interference Screw Common Name:

Screw. Fixation, Bone Classification Name:
Establishment Name & Registration Number: सं

Tornier S.A. Name:

8020756 Number:

1. Classification:
  Screw, Fixation, Bone, as categorized under 21 CFR, § 888.3040.

& 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 reconstruction, 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.

Device Class: Class II Classification Panel: Orthopaedic Product Code: 87HWC

4. Company Contact:

Ms. Patricia Abraham, Marketing Manager Tornier, S.A. B.P. 11 - rue Doyen Gosse 38330 - Saint Ismier France 011.334.7652.8000 011.334.7652.0673 - fax

5. Special Controls:

Special Controls do not apply to this device.

6. Substantially Equivalent Device(s):

1. BioScrew Fixation System. Linvatec, Inc., K933719
1. Acufex Screw, Acufex Microsurgical, Inc., K895711

7. Indications for use:

1. Surgical repair of the anterior cruciate ligament.
1. ACL repair.
1. Arthroscopic ACL repair.

8. Description of the Device:

Materials:

The material used to construct the device is described as an a -hydroxy-acid. Specifically, the material used in the construction of the Plusis® Absorbable Interference Screw is an exclusively lactic stereccopolymer containing PLA98 (98% L-lactic units and 2% D-lactic units. Resorption of PLA98 occurs exclusively by a chemical mechanism known as autocatalytic hydrolysis leading to progressive breaking of the macromolecular chains. The 2% of D-lactic units guarantee permanent hydrolysis of a PLA98 implant until its complete resorption.

Instrumentation:

Specialized instruments are provided as a part of the Phusis® Interference Screw system. There is a cannulated hex screw driver, a non-cannulated hex screw driver, a conformator (thread tap) a clearance template and a gauge. Guide wires of the appropriate diameter are also available with the system.

9. Claims Regarding Device Features, Performance, or Safety:

Surgical technique essentially the same as for metallic interference screws. 1.
1. Ease of use.
1. obviates the need for secondary surgery to remove the screw after healing.
Long history of safe use of Poly L-lactic acid material for same and similar uses. ব
strong initial and intermediate fixation followed by complete resorption. ട്.

10. Cleaning/Sterilization/Re-sterilization:

The implantable product is supplied sterile from the manufacturer. The device may not be secondarily cleaned or resterilized. Once the product packaging is opened or damaged, the product is no longer considered sterile. Inspect all packaging on arrival for evidence of shipping damage. Damaged packaging renders the product unsafe and it should not be used. Return all shipping damaged product promptly. Subsequently damaged product packaging requires product replacement. Product used in the operating room must be opened and placed into use using accepted operating room sterile technique.

The surgical instruments required to properly use the device are supplied clean only and must be sterilized prior to each use. Remove all shipping and packaging materials before sterilization. Wash all instruments thoroughly prior to sterilization. For the instruments, the recommended method is steam autoclave sterilization. The recommended sterilization cycle is based on AAMI guidelines. The cvcle is saturated steam at 270° F for 30 minutes.

11. Equivalence:

Based on the materials, intended uses, design and clinical technique, the Phusis® Absorbable Interference Screw is substantially equivalent to the above referenced legally marketed BioScrew Fixation System available from Linvatec, Inc.

FEATURE	Phusis Screw	BioScrew	Acufex	SE?
Indications for Use(s):	ACL reconstruction	same	same	Yes
Design:	cylindrical headless cannulated
tapered cancellous thread
interference screw	same	same	Yes
Sterility Assurance Level	SAL 10-8	same	same	Yes
Sterilization Method:	Hydrogen Peroxide Plasma	Gamma	Unsterile	Yes
Sizes	4	same	same	Yes
Material:	PLA98	PLA	Titanium	Yes/no
Accessory Items:	Specialized Surgical Instruments	same	same	No
Manufacturer:	Phusis	Linvatec, Inc.	Acufex Microsurgical	Yes
Product Code:	87HWC	same	same	Yes
K - Number	Pending	K933719	K895711	Yes

12. Feature Comparison Table:

13. Clinical Summary:

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, conveying a sense of authority and trustworthiness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1998

Mr. David W. Schlerf Buckman Company, Inc. Representing Tornier S.A. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389

K970829 Re: Phusis® Absorbable Interference Screw Requlatory Class: II Product Codes: MAI and HWC November 3, 1998 Dated: Received: December 7, 1998

Dear Mr. Schlerf:

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, Druq, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ 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. concerning your device in the Federal Register. Please note: 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.

Page 2 - Mr. David W. Schlerf

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

1 Page 1 ---র্ত

K970829 510(k) Number:

Phusis® Absorbable Interference Screw Device Name:

Intended Use:

1. Interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
  Specific Indications For Use:
1. Open Surgical Reconstruction of the Anterior Cruciate Ligament (ACL)
1. Arthroscopic ACL Reconstruction

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

cosello

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 14970829

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)