# Cleared is not approved, and the difference matters *Cleared Is Not Approved | PRP Mesa* > PRP Mesa separates approval of a blood-spinning machine from proof that a PRP shot helps joint soreness. Here you'll learn what cleared and approved mean before you pay, with each word tied to the machine, the shot, or your aching joint. We'll keep it plain. It isn't complicated once each word names the right thing. ## Cleared describes the blood-spinning machine, not the shot The letters PRP stand for platelet-rich plasma. It is a shot prepared after your blood is drawn and spun into layers by a clinic machine. Platelets are blood cells that clump after a cut and release signals that begin repair, and the useful fluid goes into the syringe. A clinic page or handout may say that the machine is cleared. That statement only concerns the machine's job of separating blood. It doesn't mean the PRP shot is approved for joint soreness or promise that your joint will improve. ## A written price tells you exactly what you are buying Patients often pay the PRP bill themselves, so you may request a complete written price before deciding. The total can name the visit, the procedure, and any later check. Official wording shouldn't hide a simple cost. You can also ask who gives the shot and its exact location. A clear answer will say whether it goes into your joint or tendon. Ask what soreness or swelling may follow, and you'll have time to consider the answers at home. ## Soreness that will not ease can be checked at a clinic When joint soreness keeps getting in your way, QC Kinetix provides regenerative treatment options. The clinic uses that term for non-surgical care it prepares there with material drawn from your blood. Concentrated PRP is among those choices, and the clinicians serving as medical providers examine you before deciding whether it may fit. Past X-rays and the name of each blood thinner may be useful during your visit. Ask what the clinician learned and what improvement would be reasonable. The answer may point you toward other care, and that can still make the visit worthwhile. ## Sources 1. The devices used to spin PRP at the point of care are cleared by FDA as clinical centrifuges, product code JQC, a Class I device under 21 CFR 862.2050 - for example the Biomet GPS Platelet Separation Kit (K030555, cleared 2003) and the Harvest SmartPrep2 / SmartPrep Platelet Concentration System (K103340, cleared 2010). That clearance covers the equipment that separates blood. It is not an FDA approval of platelet-rich plasma as a treatment for osteoarthritis, tendinopathy or any other orthopedic condition, and copy must never blur the two. U.S. Food and Drug Administration (Center for Devices and Radiological Health) — [510(k) Premarket Notification database and Product Classification: JQC, Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, 21 CFR 862.2050](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=JQC). *FDA accessdata (CDRH device databases)*, 2003. 2. Medicare's national coverage policy covers autologous platelet-rich plasma ONLY for patients with chronic non-healing diabetic, pressure and/or venous wounds, and only within an approved coverage-with-evidence-development clinical study. There is no Medicare national coverage for PRP in osteoarthritis or tendinopathy, which is why these injections are billed to the patient as cash-pay. Centers for Medicare & Medicaid Services — [Autologous Platelet-rich Plasma (Coverage with Evidence Development)](https://www.cms.gov/medicare/coverage/evidence/plasma). *CMS.gov*, 2024. 3. FDA states verbatim of stem cell, stromal vascular fraction, umbilical cord blood, Wharton's jelly, amniotic fluid and exosome products: 'None of these products have been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.' The only FDA-approved stem cell products in the United States are blood-forming cells from umbilical cord blood, approved only for disorders of blood production, and there are no FDA-approved exosome products. PRP is a different product from all of these and the categories must not be blurred in either direction. U.S. Food and Drug Administration — [Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes](https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes). *FDA (Center for Biologics Evaluation and Research)*, 2020. 4. In January 2025 the FTC and the Georgia Attorney General obtained federal court orders permanently BANNING the co-founders of the Stem Cell Institute of America and related companies from marketing stem cell therapy, plus $5,155,146 in civil penalties and consumer refunds. The court found on summary judgment that the defendants published false and misleading advertisements about the efficacy and approval of stem cell injections for conditions including osteoarthritis; the affiliated clinic had charged up to $5,000 per injection, almost exclusively to elderly and disabled consumers. Federal Trade Commission — [Stem Cell Institute Co-Founders and Companies Banned from Marketing Stem Cell Treatments and Ordered to Pay More Than $5.1 Million for Refunds and Civil Penalties](https://www.ftc.gov/news-events/news/press-releases/2025/01/stem-cell-institute-co-founders-companies-banned-marketing-stem-cell-treatments-ordered-pay-more-51). *FTC Press Release*, 2025. ## A clinic can examine soreness that keeps returning When the ache hasn't settled, QC Kinetix has regenerative treatment options. In plain words, this is non-surgical care made at the clinic with material drawn from your blood. One choice is PRP, or platelet-rich plasma, prepared by spinning the blood and saving fluid with many platelets. Those cells help a cut clot and send repair signals. The clinicians serving as medical providers examine you and consider your health and earlier care first. Most Mesa readers use Chandler. North and northeast Mesa may find Scottsdale easier, and you can call (602) 837-PAIN when you're ready to talk. Book a free consultation: --- A calm welcome for the joint that hurts. PRP Mesa covers lasting soreness, simple relief at home, warning signs, and what happens during a clinic visit. Mesa answers for readers who are weighing care for an aching joint. This site is operated by the owners of the QC Kinetix Phoenix-area clinics, including the Chandler and Scottsdale offices named here, and the business may benefit when a reader books a consultation. Copyright 2026 Mesa PRP Label Guide. General education only; a web page cannot diagnose a joint or replace care from a qualified medical professional.