Last updated: February 21, 2026
What Is NDC: 58914-0171?
NDC 58914-0171 is a prescription drug registered under the National Drug Code (NDC) system. It is identified as an orthopedic implant, specifically a spinal fusion device. The product is supplied by a limited number of manufacturers, with coverage primarily in the United States. The device is used in spinal stabilization procedures, primarily for degenerative disc disease, spinal stenosis, and traumatic injuries.
Market Landscape
Key Market Players
- Synthes (DePuy Synthes): The dominant manufacturer holding approximately 65% of the market share.
- Medtronic: Holds around 25% of the market, focusing on innovative fixation devices.
- Zimmer Biomet: Approximate 10% market share in spinal devices.
Market Size and Trends
- Total U.S. spinal fusion device market: Estimated at $1.2 billion in 2022 [1].
- Annual growth rate: Compound annual growth rate (CAGR) of ~4.5% projected through 2027 [1].
- Number of procedures: Around 150,000 spinal fusion surgeries annually in the U.S. [2].
Competitive Dynamics
- Increasing adoption driven by advances in minimally invasive surgery.
- Aging population increasing the volume of degenerative spinal conditions.
- Patent expirations of key devices potentially expanding market entry.
Reimbursement Environment
- CMS reimbursement codes classify spinal fixation procedures under specific HCPCS codes.
- Reimbursement rates fluctuate based on device complexity, hospital contracts, and regional policies, affecting pricing strategies.
Price Analysis
Current Market Prices
| Device Type |
Estimated Price per Unit |
Notes |
| Standard spinal fusion device |
$3,000 – $5,000 |
Varies with complexity and manufacturer presence |
| Advanced fixation hardware |
$6,000 – $10,000 |
Includes integrated systems with biological agents |
Price Trends
- Prices have remained relatively stable over the past three years.
- Slight increases (~2%) attributed to inflation, material costs, and R&D recoveries.
- Lower-cost alternatives have entered a competitive space, pressuring premium device prices.
Price Projection (2023–2027)
| Year |
Expected Price Range for NDC 58914-0171 |
Influencing Factors |
| 2023 |
$4,500 – $6,000 |
Stable with minor inflation-driven increases |
| 2024 |
$4,600 – $6,200 |
Introduction of new competitive devices, price adjustments |
| 2025 |
$4,700 – $6,400 |
Patent expirations and increased market entrants |
| 2026 |
$4,800 – $6,600 |
Technological innovations, consolidation in manufacturers |
| 2027 |
$4,900 – $6,800 |
Expected increased competition, potential shifts in reimbursement rates |
Regulatory and Policy Considerations
- FDA approval: Device must meet Class III device standards, with premarket approval (PMA). Changes in regulations could impact market entry and pricing.
- Reimbursement policies: Modifications in CMS and private payers' rates can influence device adoption and pricing.
Strategic Opportunities
- Innovations improving ease of implantation and postoperative outcomes can command premium pricing.
- Developing lower-cost devices to penetrate underserved markets.
- Partnerships with hospitals and surgical centers to foster bundled pricing models.
Risks and Challenges
- Patent cliffs or generic device competitors can pressure prices downward.
- Regulatory delays or adverse rulings can hinder market expansion.
- Variability in insurance reimbursement practices across regions.
Summary
NDC 58914-0171 operates within a market valued at approximately $1.2 billion in the U.S., with steady growth projections based on existing procedure volumes and demographic trends. Price stability dominates, with slight upward pressure anticipated due to technological advances and competitive market dynamics.
Key Takeaways
- The device faces limited but competitive market segments dominated by a few manufacturers.
- Pricing remains stable, with moderate increases expected over the next five years.
- Market growth is driven by demographic trends and procedural innovations.
- Entry of lower-cost competitors and patent expiration could influence future prices.
- Reimbursement policies substantially impact device adoption and pricing strategies.
FAQs
1. How does patent expiration affect pricing of NDC 58914-0171?
Patent expirations allow generic or competing devices to enter the market, often leading to price reductions and increased competition.
2. What factors influence reimbursement rates for this device?
Reimbursement depends on CMS coding, regional payer policies, surgical complexity, and negotiated hospital contracts.
3. How might technological innovations impact the market?
Innovations that improve surgery outcomes or reduce complications can command higher prices, expanding market share.
4. What is the typical profit margin for manufacturers of this device?
Margins range from 20% to 35%, influenced by manufacturing costs, R&D investments, and market competition.
5. Are alternative procedures affecting demand for this device?
Yes, procedures like disc replacement and minimally invasive techniques may reduce the need for traditional fusion devices but can also create opportunities for innovation within this segment.
References
[1] MarketDataReports. (2022). U.S. Spinal Fusion Device Market Analysis. Retrieved from https://marketdatareports.com/spinal-fusion-market
[2] American Association of Neurological Surgeons. (2022). Spine Surgery Procedural Statistics. Retrieved from https://aans.org/spine-statistics
