Riverpoint Medical: FDA clearances and approvals
Riverpoint Medical has 39 FDA 510(k) clearances (first 2009, latest 2026), across 11 product codes in 4 review panels. Median 510(k) review time: 52 days. Since 2017 its median was 30 days, against 91 days for all cleared 510(k)s in the same product codes. openFDA lists 47 product recalls by a recalling firm named Riverpoint Medical. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 89 |
| 2013 | 0 | — |
| 2014 | 1 | 36 |
| 2015 | 2 | 117 |
| 2016 | 2 | 88 |
| 2017 | 1 | 53 |
| 2018 | 0 | — |
| 2019 | 1 | 30 |
| 2020 | 2 | 30 |
| 2021 | 1 | 52 |
| 2022 | 0 | — |
| 2023 | 8 | 42 |
| 2024 | 9 | 29 |
| 2025 | 4 | 28 |
| 2026 | 3 | 98 |
Review time against the same product codes
Since 2017, Riverpoint Medical's cleared 510(k)s took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 23 | 23 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 7 | 7 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
| LZU | Plug, Punctum | 1 | 1 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (25)
- General and Plastic Surgery (12)
- Ophthalmic (1)
- Radiology (1)
Most recent Riverpoint Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262677 | Iconix Knotless T | MBI | 2026-08-27 | 28 |
| K253693 | Strut Suture; No-Tie Button | MBI | 2026-03-11 | 110 |
| K253695 | LigaMend | MBI | 2026-02-27 | 98 |
| K253024 | ProZip Knotless Implant | GAT | 2025-10-16 | 27 |
| K252201 | HS Fiber | GAT | 2025-08-13 | 30 |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor | MBI | 2025-07-30 | 22 |
| K243988 | RootMend MRR | MBI | 2025-03-20 | 84 |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct | MBI | 2024-11-26 | 96 |
| K243323 | Iconix Knotless Anchor | MBI | 2024-11-19 | 27 |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | MBI | 2024-10-29 | 28 |
29 earlier clearances. See the full list in Caduvo.
Recalls
47 product recalls in 7 recall events; 1 initiated in the last five years. Most recent: 2023-10-25.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Riverpoint Medical is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05762588: JuggerKnot With Broadband PMCF Study (Active not recruiting, started 2023-11-30)
Frequently asked questions
How many FDA 510(k) clearances does Riverpoint Medical have?
Riverpoint Medical has 39 FDA 510(k) clearances (first 2009, latest 2026), across 11 product codes in 4 review panels.
How long does FDA take to clear Riverpoint Medical's 510(k)s?
The median time from FDA receipt to decision across Riverpoint Medical's cleared 510(k)s is 52 days. Since 2017: 30 days, versus 91 days for all cleared 510(k)s in the same product codes.
What devices does Riverpoint Medical make?
Its most frequent FDA product codes are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 23); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 7); GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 1).
Has Riverpoint Medical had device recalls?
openFDA lists 47 product recalls in 7 recall events by a recalling firm whose name matches Riverpoint Medical; the most recent began 2023-10-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 39 Riverpoint Medical clearances with predicates and recalls
- Run predicate analysis for product code MBI, Riverpoint Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.