Who is the manufacturer of LM BONE ANCHOR?

Li Medical Technologies, Inc. filed the 510(k) submission for LM BONE ANCHOR (K963288).

What is the FDA product code for LM BONE ANCHOR?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for LM BONE ANCHOR?

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

What are the predicate devices for LM BONE ANCHOR?

Mitek Surgical Products GII QuickAnchor (K904436); Li Medical Bone Anchor (K951233); Li Medical Bone Anchor (K951472); Li Medical Bone Anchor (K953764); Li Medical Bone Anchor (K960448); Li Medical Bone Anchor (K960439); Li Medical Bone Anchor (K960825).

Who can help prepare an FDA 510(k) submission like LM BONE ANCHOR?

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.

LM BONE ANCHOR

K963288 · Li Medical Technologies, Inc. · MBI · Nov 13, 1996 · Orthopedic

Device Facts

Record ID	K963288
Device Name	LM BONE ANCHOR
Applicant	Li Medical Technologies, Inc.
Product Code	MBI · Orthopedic
Decision Date	Nov 13, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Bladder neck suspension for female urinary incontinence due to urethral hypermobility. Fixation in pubic bone for the purpose of bladder neck suspension using USP #2 Class I, non-absorbable, synthetic suture (e.g., polypropylene). A minimum of two LM Anchors should be used in this (modified MMK, Raz, or Stamey, i.e., Benderev) procedure.

Device Story

Bone anchor system for soft tissue-to-bone attachment; used in bladder neck suspension procedures. Device consists of crown and center pin for suture passage. Implanted into pubic bone by surgeons. Provides mechanical fixation for sutures; facilitates tissue stabilization. Benefits patients by restoring bladder neck support to treat urinary incontinence.

Clinical Evidence

Bench testing only. Pre-clinical cadaver specimen study compared mean pullout strength of LM Anchor Products to Mitek anchors, showing substantial equivalence.

Technological Characteristics

Materials: 316L surgical grade stainless steel or 6Al-4V ELI titanium. Design: Cylindrical anchor with crown and center pin for suture passage. Fixation mechanism: Cantilevered beams.

Indications for Use

Indicated for female patients with urinary incontinence due to urethral hypermobility requiring bladder neck suspension.

Regulatory Classification

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.

Predicate Devices

Mitek Surgical Products GII QuickAnchor (K904436)
Li Medical Bone Anchor (K951233)
Li Medical Bone Anchor (K951472)
Li Medical Bone Anchor (K953764)
Li Medical Bone Anchor (K960448)
Li Medical Bone Anchor (K960439)
Li Medical Bone Anchor (K960825)

Related Devices

K992277 — STAPLETAC BONE ANCHOR SYSTEM · Influence, Inc. · Jul 30, 1999
K962372 — UROTAC BONE ANCHOR INSERTER · Influence, Inc. · Aug 19, 1996
K971139 — BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT · Boston Scientific Corp · Jun 25, 1997
K963402 — INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER · Innovasive Devices, Inc. · Nov 4, 1996
K990295 — BONE ANCHOR SYSTEM III (BAS III) · Boston Scientific Corp · Mar 5, 1999

Submission Summary (Full Text)

{0} NOV 13 1996 K963288 # 510(K) SUMMARY | Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484, 203-944-2800 | | --- | --- | | Contact: | Rhodemann Li, Vice President | | Date: | October 30, 1996 | | Classification Name: | Staple, Fixation, Bone | | Common Name: | Bone anchor | | Proprietary Name: | LM Anchor Products or other proprietary names | | Predicate Devices: | Mitek Surgical Products GII QuickAnchor (K904436) Li Medical Bone Anchor (K951233), (K951472), (K953764), (K960448), (K960439), (K960825) | | Device Description: | Made from surgical grade stainless steel (316L) or titanium (6Al-4V ELI), the LM Anchor Products are designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment. | | Intended Use: (UltraFix RC, UltraFix Mini, UltraFix) | Bladder neck suspension for female urinary incontinence due to urethral hypermobility. Fixation in pubic bone for the purpose of bladder neck suspension using USP #2 Class I, non-absorbable, synthetic suture (e.g., polypropylene). A minimum of two LM Anchors should be used in this (modified MMK, Raz, or Stamey, i.e., Benderev) procedure. | | Technical Comparison: | The LM Anchor Products are similar to the Mitek anchors in its cylindrical shape; however, the bony purchase is accomplished by the LM Anchor Products through cantilevered beams versus nitinol arcs with the Mitek anchors. | | Performance Data: | Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor Products were substantially equivalent to the mean pullout strength of the Mitek anchors. | S1 d