Who can help prepare an FDA 510(k) submission like APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)?

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.

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)

Q: Who is the manufacturer of APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)?

Omni Life Science, Inc. filed the 510(k) submission for APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) (K082468).

Q: What is the FDA product code for APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)?

KWY. It is classified under 21 CFR 888.3390 as a Class 2 device in the Orthopedic panel.

Q: What is the regulatory pathway for APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)?

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

Q: What are the predicate devices for APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)?

Pivot Bipolar Femoral Head (K050966); PLUS Bipolar Prosthesis (K982447); BioPro Bipolar Head (K082705).

K082468 · Omni Life Science, Inc. · KWY · Feb 18, 2009 · Orthopedic

Device Facts

Record ID	K082468
Device Name	APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)
Applicant	Omni Life Science, Inc.
Product Code	KWY · Orthopedic
Decision Date	Feb 18, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3390
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: Femoral neck and trochanteric fractures of the proximal femur; Osteonecrosis of the femoral head; Revision procedures where other devices or treatments for these indications have failed.

Device Story

Apex Hip System Bipolar Head is a hemi-hip prosthesis for uncemented primary or revision arthroplasty. Device consists of a factory-assembled UHMWPE liner, cobalt chrome outer shell, and UHMWPE retention ring. Outer diameters range 38-60 mm; inner diameters mate with 22 mm or 28 mm femoral heads. Used in combination with Apex Hip System femoral stems (Apex K1, K2, or Modular). Implanted by surgeons in clinical settings to replace the femoral head, restoring joint function and addressing fractures or osteonecrosis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Cobalt chrome outer shell (ASTM F75), UHMWPE liner and retention ring (ASTM F648). Design: Bipolar hemi-hip prosthesis, self-aligning eccentric head. Sterilization: EtO. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring uncemented primary or revision hemiarthroplasty of the hip due to femoral neck/trochanteric fractures, osteonecrosis of the femoral head, or failed prior treatments/devices.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Predicate Devices

Pivot Bipolar Femoral Head (K050966)
PLUS Bipolar Prosthesis (K982447)
BioPro Bipolar Head (K082705)

Related Devices

K100151 — APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) · Omnlife Science · May 28, 2010
K100761 — BIOPRO POLAR HEAD · Biopro, Inc. · Dec 3, 2010
K132539 — RING-LOK MODULAR BIPOLAR SYSTEM · Implants International, Ltd. · Feb 7, 2014
K082705 — BIOPRO BIPOLAR HEAD, MODELS 18130-18152 · Biopro, Inc. · Dec 15, 2008
K191297 — iNSitu Bipolar Hip System · Theken Companies, LLC · Sep 17, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for OMNIlife science. The logo consists of a circular symbol with a hole in the center, positioned above the text "OMNIlife science". The word "science" has a trademark symbol next to it. FEB 1 8 2009 510(K) Summary ## K 082468 ## Apex Hip System Bipolar Head ### January 14, 2009 - OMNI life science, Inc. 1. Submitter: 175 Paramount Drive Raynham, MA 02787 - Contact: William McCallum Requiatory and Quality Systems (508) 824-2444 x413 #### 2. Device Name Proprietary Name: Apax Hip System Bipolar Head Common Name: Hemi-hip prosthesis, uncemented Classification Name: Hip joint femoral (hemi-hip) metalloolymer comented or uncemented prosthesis Regulatory Class: Class II per 21 CFR \$888.3390 #### 3. Intended Use The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemlarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: - 争 Femoral neck and trochanteric fractures of the proximal femur: - Osteonecrosis of the femoral head; 사 - Revision procedures where other devices or treatments for these indications have failed. #### 4. Device Description The Apex Hip System Bipolar Head consists of a factory assembled UHMVPE IIner in a coball chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the palient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bloolar heads (43 mm to 60 mm) have en inner diameter that mates with a 28 mm diameter temoral head. The Agex Hip System Bipolar Head may be used for hemiarthroplasty in conjunction with the following Apex Hip System femoral stems: Apox K1 ™ , Apex K2 ™ , and Apex Modular™ Page 1 of 2 {1}------------------------------------------------ ## 5. Predicate Device Comparison Substantial equivalence is claimed to the Pivot Bipofar Femoral Head (KO50966) distributed by Ortho Development, the PLUS Bipciar Prosthesis (K982447) distributed by Plus Orthopaedics (now Smith & Nephew), and the BioPro Bipolar Head (K082705). The following table summarizes the similarities and differences between the Apex Hip System Bipolar Head and these predicate devices: | | Apex Hip System Bipolar Head | Ortho Development Pivot Bipolar | Plus Orthopedics PLUS Bipolar | BioPro Bipolar Head | |------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------| | 510(k) Number | Pending | K050966 | K982447 | K082705 | | FDA Product Code | KWY | KWY | KWY | KWY | | DESIGN | | | | | | Liner-Shell | UHMWPE- CoCr | UHMWPE- CoCr | UHMWPE- CoCr | UHMWPE CoCr | | Head Outer Diameter | 38 to 60 mm in 1 mm increments | 38 to 60 mm in 1 mm increments | 43 to 60 mm in 1 mm increments | 38 to 60 mm in 1 mm increments | | Self- aligning (eccentric head) | Yes | Yes | Yes | Yes | | Liner Inner Diameter | 22.225 or 28 mm | 22.225 or 28 mm | 28 mm | 22.225 or 28 mm | | Liner-Head Assembly | Head snap-fit into bipolar liner | Head snap-fit into bipolar liner | Head held in by retention ring | Head snap-fit into bipolar liner | | UHMWPE retention ring | Yes | Yes | Yes | Yes | | MATERIALS | | | | | | Femoral head | CoCr or alumina ceramic | Cobalt chromium (CoCr) | Cobalt chromium (CoCr) | CoCr or alumina ceramic | | Outer shell | Cobalt chromium (ASTM F75) | Cobalt chromium (ASTM F75) | Cobalt chromium (ASTM F75) | Cobalt chromium (ASTM F75) | | Liner and retention ring | UHMWPE (ASTM F648), EtO sterilized (not highly crosslinked) | UHMWPE (ASTM F648), gamma sterilized (not highly crosslinked) | UHMWPE (ASTM F648), EtO sterilized (not highly crosslinked) | UHMWPE (ASTM F648), EtO sterilized (not highly crosslinked) | Page 2 of 2 {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular fashion around the symbol. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # FEB 1 8 2009 OMNI Life Science, Inc. % Mr. William McCallum Director, Regulatory and Quality Systems 175 Paramount Drive Raynham, Massachusetts 02767 Re: K082468 Trade/Device Name: Apex Hip System Bipolar Head Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Dated: January 14, 2009 Received: January 15, 2009 Dear Mr. McCallum: 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 - Mr. William McCallum Enclesure 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)); please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health yy) {4}------------------------------------------------ # Indications for Use 610(k) Number (if known): K082468 Device Name: Apex Hip System Bipolar Head Indications for Use: The Apex Hip System Bipolar Head Is Intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revilsion hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: . Femoral neck and tracteric fracteres of the proximal temur: చెన్ని - Osteonecrosis of the femoral head; - Revision procedures where other devices ar treatments for these indications have failed. Presoription Use X (Per 21 CF61801 Subpart D) ANDIOR Over-The Counter Use, 23 CFR 801 Subpert C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorativest and Neurological Devices 510(k) Number.