Reform TI Pedicle Screw System
Model 39-SG-5550 · PRECISION SPINE, INC. · DI 00840019940078
KWP — Appliance, Fixation, Spinal Interlaminal · Class II · 21 CFR 888.3050
MNH — Orthosis, Spondylolisthesis Spinal Fixation · Class II · 21 CFR 888.3070
MNI — Orthosis, Spinal Pedicle Fixation · Class II · 21 CFR 888.3070
NKB — Thoracolumbosacral Pedicle Screw System · Class II · 21 CFR 888.3070
OSH — Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis · Class II · 21 CFR 888.3070
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (6)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Injury: 6
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.15 |
| 2019-02 | 0 | 1.97 |
| 2019-03 | 0 | 2.01 |
| 2019-04 | 0 | 2.03 |
| 2019-05 | 0 | 2.33 |
| 2019-06 | 0 | 2.54 |
| 2019-07 | 0 | 1.69 |
| 2019-08 | 0 | 2.86 |
| 2019-09 | 0 | 1.78 |
| 2019-10 | 0 | 1.92 |
| 2019-11 | 0 | 2.33 |
| 2019-12 | 0 | 1.65 |
| 2020-01 | 0 | 2.37 |
| 2020-02 | 0 | 2.26 |
| 2020-03 | 0 | 2.21 |
| 2020-04 | 0 | 1.64 |
| 2020-05 | 0 | 2.41 |
| 2020-06 | 0 | 1.84 |
| 2020-07 | 0 | 1.86 |
| 2020-08 | 0 | 1.95 |
| 2020-09 | 0 | 2.42 |
| 2020-10 | 0 | 2.64 |
| 2020-11 | 0 | 2.4 |
| 2020-12 | 6 | 2.09 |
| 2021-01 | 0 | 2.31 |
| 2021-02 | 0 | 1.88 |
| 2021-03 | 0 | 2.48 |
| 2021-04 | 0 | 2.27 |
| 2021-05 | 0 | 2.01 |
| 2021-06 | 0 | 1.93 |
| 2021-07 | 0 | 6.33 |
| 2021-08 | 0 | 1.98 |
| 2021-09 | 0 | 1.78 |
| 2021-10 | 0 | 2.6 |
| 2021-11 | 0 | 2.27 |
| 2021-12 | 0 | 2.31 |
| 2022-01 | 0 | 2.16 |
| 2022-02 | 0 | 1.96 |
| 2022-03 | 0 | 1.84 |
| 2022-04 | 0 | 1.98 |
| 2022-05 | 0 | 1.78 |
| 2022-06 | 0 | 2.05 |
| 2022-07 | 0 | 4.13 |
| 2022-08 | 0 | 1.9 |
| 2022-09 | 0 | 2.84 |
| 2022-10 | 0 | 1.45 |
| 2022-11 | 0 | 1.78 |
| 2022-12 | 0 | 2.07 |
| 2023-01 | 0 | 1.68 |
| 2023-02 | 0 | 1.8 |
| 2023-03 | 0 | 1.77 |
| 2023-04 | 0 | 1.96 |
| 2023-05 | 0 | 1.59 |
| 2023-06 | 0 | 1.75 |
| 2023-07 | 0 | 1.92 |
| 2023-08 | 0 | 1.6 |
| 2023-09 | 0 | 2.8 |
| 2023-10 | 0 | 2.78 |
| 2023-11 | 0 | 2.64 |
| 2023-12 | 0 | 1.7 |
| 2024-01 | 0 | 2.52 |
| 2024-02 | 0 | 2.21 |
| 2024-03 | 0 | 3.9 |
| 2024-04 | 0 | 1.78 |
| 2024-05 | 0 | 3.55 |
| 2024-06 | 0 | 2.18 |
| 2024-07 | 0 | 1.93 |
| 2024-08 | 0 | 1.99 |
| 2024-09 | 0 | 2.67 |
| 2024-10 | 0 | 2.09 |
| 2024-11 | 0 | 2.15 |
| 2024-12 | 0 | 1.84 |
| 2025-01 | 0 | 2.24 |
| 2025-02 | 0 | 2.54 |
| 2025-03 | 0 | 2.41 |
| 2025-04 | 0 | 2.41 |
| 2025-05 | 0 | 2.25 |
| 2025-06 | 0 | 2.13 |
| 2025-07 | 0 | 2 |
| 2025-08 | 0 | 1.91 |
| 2025-09 | 0 | 1.92 |
| 2025-10 | 0 | 2.01 |
| 2025-11 | 0 | 2 |
| 2025-12 | 0 | 2.36 |
| 2026-01 | 0 | 2.47 |
| 2026-02 | 0 | 2.46 |
| 2026-03 | 0 | 2.56 |
| 2026-04 | 0 | 1.84 |
| 2026-05 | 0 | 1.99 |
| 2026-06 | 0 | 4.69 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K150856 — cites (transitively): K022949 (d1), K031175 (d1), K071438 (d1), K073240 (d1), K090033 (d1), K092128 (d1), K121172 (d1), K130279 (d1), K131343 (d1), K143248 (d1), K992739 (d1), K061520 (d2), K131615 (d2), K133746 (d2), K090203 (d3), K000476 (d3), K003822 (d3), K022285 (d3), K082572 (d3), K090523 (d3), K091067 (d3), K905826 (d3), K950099 (d3), K962984 (d3), K974749 (d3) — cited as predicate by K200303, K242297
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — PRECISION SPINE, INC.
- NAI 2017-08-11 Precision Spine Inc · 0 citations