Who is the manufacturer of ESOP CO-CR FEMORAL HEADS?

Fournitures Hospitalieres filed the 510(k) submission for ESOP CO-CR FEMORAL HEADS (K021109).

What is the FDA product code for ESOP CO-CR FEMORAL HEADS?

LPH. It is classified under 21 CFR 888.3358 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ESOP CO-CR FEMORAL HEADS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ESOP CO-CR FEMORAL HEADS?

Headloc™ Femoral Head (K953977); Primaloc® Cementless Hip System (K953977); Intrinsic® Cementless Total Hip System (K923911); Exactech AcuMatch Hip System (K010081).

Who can help prepare an FDA 510(k) submission like ESOP CO-CR FEMORAL HEADS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ESOP CO-CR FEMORAL HEADS

K021109 · Fournitures Hospitalieres · LPH · Jun 12, 2002 · Orthopedic

Device Facts

Record ID	K021109
Device Name	ESOP CO-CR FEMORAL HEADS
Applicant	Fournitures Hospitalieres
Product Code	LPH · Orthopedic
Decision Date	Jun 12, 2002
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Prosthetic replacement of the femoral head associated with hip prosthesis, which cone is compatible with the head's cone and with a prosthetic acetabular cup, whose diameter is compatible with the head.

Device Story

Metallic femoral head prosthesis; chrome cobalt construction; designed for adaptation to machined cones on femoral stems. Available in multiple diameters and neck lengths (short, medium, long, extra-long collars) to facilitate full or intermediary hip replacement. Used in orthopedic surgery for hip arthroplasty. Device provides structural replacement of femoral head; interfaces with compatible prosthetic acetabular cups. Enables restoration of hip joint function in patients with degenerative, inflammatory, or traumatic conditions.

Clinical Evidence

Bench testing only. Laboratory testing conducted to characterize materials and support substantial equivalence.

Technological Characteristics

Chrome cobalt femoral heads; diameters 28mm and 32mm; cone dimensions 12/14 (5°43') and 10/12 (6°). Designed for cementless application. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients with degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows sufficient sound bone to seat the prosthesis. Intended for cementless application.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

Headloc™ Femoral Head (K953977)
Primaloc® Cementless Hip System (K953977)
Intrinsic® Cementless Total Hip System (K923911)
Exactech AcuMatch Hip System (K010081)

Related Devices

K023375 — MODIFICATION TO ESOP CO-CR FEMORAL HEADS · Pro-Active Healthcare · Oct 25, 2002
K063278 — PORTLAND COBALT CHROME FEMORAL HEAD · Portland Orthopaedics Limited · Jan 12, 2007
K030205 — CONSENSUS UNIPOLAR HEAD, COCR · Hayes Medical, Inc. · Apr 1, 2003
K965019 — THE C-FIT FEMORAL HIP SYSTEM · Corin USA · Mar 25, 1997
K062408 — SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD · Smith & Nephew, Inc. · Sep 12, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ 1 | JUN 12 2002 | K021109 page 1 of 2 | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 510 (K) SUMMARY - Metallic Femoral Head | | Submitter name: | Fournitures Hospitalières Industrie | | Submitter adress: | 6 Rue Nobel, Z.I. de Kernevez QUIMPER, France 29000 | | Contact person: | Mrs Christine QUENDEZ | | Phone Number: | +33.2.98.55.68.95 | | Fax Number: | +33.2.98.53.42.13 | | Date prepared: | April 5, 2002 | | Device Trade Name: | Metallic Femoral Head | | Device common name: | Femoral head | | Classification name: | Hip joint metal/polymer/metal semi-constrained porous- coated uncemented prosthesis | | Predicate Device: | Headloc™ Femoral Head Primaloc® Cementless Hip System (K953977) Ortho Development Corporation Intrinsic® Cementless Total Hip System (K923911) Ortho Max. Inc. Exactech AcuMatch Hip System (K010081) | | Device description: | The Metallic Femoral Heads are intended to be adapted to special cones machined for this purpose. Femoral head are available in several diameter for use in full hip or intermediary replacement. The length of the neck on the femoral stem can be adjusted by using the heads available in different insertion depths (short, medium, long and extra- long collars), and of different diameter. | | Intended use: | Prosthetic replacement of the femoral head associated with hip prosthesis, which cone is compatible with the head's cone and with a prosthetic acetabular cup, whose diameter is compatible with the head. | | K021109 page 2 of 2 | | | Characteristics and Comparison to Predicate Devices: | Femoral heads made of chrome cobalt (Ø 28 & 32 mm), short collar, medium collar long collar & extra-long collar with cone dimensions 12/14, 5°43' & 10/12, 6°. The identified predicate devices have the same intended use, are made of the same material, have the same size, and collar + cone dimensions are of the same order of magnitude. | | Performance Data: | Testings conducted to characterize the materials under defined laboratory conditions are provided to support a finding of substantial equivalence. | | Conclusion: | The Metallic Femoral Heads are substantially equivalent to predicate devices in terms of intended use, safety, and effectiveness. | ## Device Technological {1}------------------------------------------------ {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings. JUN 1 2 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Fournitures Hospitalières Industrie c/o Dr. Andre Weith Director, Pro-Active Healthcare c/o PharmaNet, Inc. 815 Connecticut Avenue NW, Suite 800 Washington, D.C. 20006 Re: K021109 Trade/Device Name: ESOP® Co-Cr Femoral Heads Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: April 5, 2002 Received: April 5, 2002 Dear Dr. Weith: 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Dr. Andre Weith This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark N. Millenson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Sponsor: Pro-Active 510(k) Number (if known): K02ii09 page 1 of 1 Device Name: ESOP® Co-Cr Femoral Heads Indications for Use: The ESOP® Co-Cr Femoral Heads are intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | Concurrence of CDRH; Office of Device Evaluation (ODE) | | |--|-----------------------------------------------------------|--| | | for | | | | (Division Sign-Off) | | | | Division of General, Restorative and Neurological Devices | | | Prescription Use (Per 21 CFR 801.109) | <table><tr><td>510(k) Number</td><td>K021109</td></tr><tr><td></td><td>OR Over-The-Counter Use</td></tr></table> | 510(k) Number | K021109 | | OR Over-The-Counter Use | |---------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------|---------|--|-------------------------| | 510(k) Number | K021109 | | | | | | | OR Over-The-Counter Use | | | | | (Optional Format 1-2-96)