Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Summa Orthopaedics System Bone Screw

Model SO-35-SO-L55-T · Jeil Medical Corporation · DI 08800089435906

HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040

UDILibrary device dossier · generated 2026-09-16 · 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 (0)

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.

13452019-01: 0 reports for this device; peer average 2.11/device2019-02: 0 reports for this device; peer average 1.6/device2019-03: 0 reports for this device; peer average 1.65/device2019-04: 0 reports for this device; peer average 2.23/device2019-05: 0 reports for this device; peer average 1.75/device2019-06: 0 reports for this device; peer average 1.81/device2019-07: 0 reports for this device; peer average 2.06/device2019-08: 0 reports for this device; peer average 2.03/device2019-09: 0 reports for this device; peer average 1.75/device2019-10: 0 reports for this device; peer average 1.69/device2019-11: 0 reports for this device; peer average 1.96/device2019-12: 0 reports for this device; peer average 2.52/device2020-01: 0 reports for this device; peer average 2.55/device2020-02: 0 reports for this device; peer average 2.13/device2020-03: 0 reports for this device; peer average 1.9/device2020-04: 0 reports for this device; peer average 1.87/device2020-05: 0 reports for this device; peer average 1.75/device2020-06: 0 reports for this device; peer average 2.06/device2020-07: 0 reports for this device; peer average 2.67/device2020-08: 0 reports for this device; peer average 2.5/device2020-09: 0 reports for this device; peer average 2.44/device2020-10: 0 reports for this device; peer average 2.22/device2020-11: 0 reports for this device; peer average 2.83/device2020-12: 0 reports for this device; peer average 2.48/device2021-01: 0 reports for this device; peer average 1.85/device2021-02: 0 reports for this device; peer average 2.29/device2021-03: 0 reports for this device; peer average 2.59/device2021-04: 0 reports for this device; peer average 2.7/device2021-05: 0 reports for this device; peer average 2.4/device2021-06: 0 reports for this device; peer average 2.2/device2021-07: 0 reports for this device; peer average 2.29/device2021-08: 0 reports for this device; peer average 2.07/device2021-09: 0 reports for this device; peer average 2.36/device2021-10: 0 reports for this device; peer average 2.08/device2021-11: 0 reports for this device; peer average 2.26/device2021-12: 0 reports for this device; peer average 2.35/device2022-01: 0 reports for this device; peer average 2.94/device2022-02: 0 reports for this device; peer average 2.2/device2022-03: 0 reports for this device; peer average 2.01/device2022-04: 0 reports for this device; peer average 1.94/device2022-05: 0 reports for this device; peer average 2.37/device2022-06: 0 reports for this device; peer average 2.22/device2022-07: 0 reports for this device; peer average 2.18/device2022-08: 0 reports for this device; peer average 2.48/device2022-09: 0 reports for this device; peer average 2.88/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 2.99/device2022-12: 0 reports for this device; peer average 5.49/device2023-01: 0 reports for this device; peer average 2.72/device2023-02: 0 reports for this device; peer average 2.85/device2023-03: 0 reports for this device; peer average 3.08/device2023-04: 0 reports for this device; peer average 2.76/device2023-05: 0 reports for this device; peer average 3.3/device2023-06: 0 reports for this device; peer average 2.94/device2023-07: 0 reports for this device; peer average 2.28/device2023-08: 0 reports for this device; peer average 2.16/device2023-09: 0 reports for this device; peer average 2.02/device2023-10: 0 reports for this device; peer average 2.14/device2023-11: 0 reports for this device; peer average 1.87/device2023-12: 0 reports for this device; peer average 2.44/device2024-01: 0 reports for this device; peer average 2.76/device2024-02: 0 reports for this device; peer average 1.81/device2024-03: 0 reports for this device; peer average 2.34/device2024-04: 0 reports for this device; peer average 2.12/device2024-05: 0 reports for this device; peer average 2.3/device2024-06: 0 reports for this device; peer average 2.26/device2024-07: 0 reports for this device; peer average 2.46/device2024-08: 0 reports for this device; peer average 2.14/device2024-09: 0 reports for this device; peer average 2.15/device2024-10: 0 reports for this device; peer average 2.19/device2024-11: 0 reports for this device; peer average 2.05/device2024-12: 0 reports for this device; peer average 2.76/device2025-01: 0 reports for this device; peer average 2.2/device2025-02: 0 reports for this device; peer average 2.18/device2025-03: 0 reports for this device; peer average 2.06/device2025-04: 0 reports for this device; peer average 2.54/device2025-05: 0 reports for this device; peer average 2.49/device2025-06: 0 reports for this device; peer average 2.01/device2025-07: 0 reports for this device; peer average 2.14/device2025-08: 0 reports for this device; peer average 2.39/device2025-09: 0 reports for this device; peer average 2.07/device2025-10: 0 reports for this device; peer average 2.47/device2025-11: 0 reports for this device; peer average 2.05/device2025-12: 0 reports for this device; peer average 2.73/device2026-01: 0 reports for this device; peer average 2.06/device2026-02: 0 reports for this device; peer average 2.37/device2026-03: 0 reports for this device; peer average 2.62/device2026-04: 0 reports for this device; peer average 2.17/device2026-05: 0 reports for this device; peer average 2.56/device2026-06: 0 reports for this device; peer average 2.32/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.11
2019-0201.6
2019-0301.65
2019-0402.23
2019-0501.75
2019-0601.81
2019-0702.06
2019-0802.03
2019-0901.75
2019-1001.69
2019-1101.96
2019-1202.52
2020-0102.55
2020-0202.13
2020-0301.9
2020-0401.87
2020-0501.75
2020-0602.06
2020-0702.67
2020-0802.5
2020-0902.44
2020-1002.22
2020-1102.83
2020-1202.48
2021-0101.85
2021-0202.29
2021-0302.59
2021-0402.7
2021-0502.4
2021-0602.2
2021-0702.29
2021-0802.07
2021-0902.36
2021-1002.08
2021-1102.26
2021-1202.35
2022-0102.94
2022-0202.2
2022-0302.01
2022-0401.94
2022-0502.37
2022-0602.22
2022-0702.18
2022-0802.48
2022-0902.88
2022-1003
2022-1102.99
2022-1205.49
2023-0102.72
2023-0202.85
2023-0303.08
2023-0402.76
2023-0503.3
2023-0602.94
2023-0702.28
2023-0802.16
2023-0902.02
2023-1002.14
2023-1101.87
2023-1202.44
2024-0102.76
2024-0201.81
2024-0302.34
2024-0402.12
2024-0502.3
2024-0602.26
2024-0702.46
2024-0802.14
2024-0902.15
2024-1002.19
2024-1102.05
2024-1202.76
2025-0102.2
2025-0202.18
2025-0302.06
2025-0402.54
2025-0502.49
2025-0602.01
2025-0702.14
2025-0802.39
2025-0902.07
2025-1002.47
2025-1102.05
2025-1202.73
2026-0102.06
2026-0202.37
2026-0302.62
2026-0402.17
2026-0502.56
2026-0602.32
This device (reports/month)Average device in HWC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K170313 — cites (transitively): K013248 (d1), K103705 (d1), K112812 (d1), K131311 (d1), K132876 (d1), K151468 (d1), K163044 (d1), K001941 (d2), K043185 (d2), K052614 (d2), K062863 (d2), K102343 (d2), K091679 (d2), K103778 (d2), K023360 (d2), K023365 (d2), K063875 (d2), K112457 (d2), K062498 (d2), K103332 (d2), K142906 (d2), K000684 (d2), K073460 (d2), K102429 (d2), K131093 (d2), K962823 (d3), K082320 (d3), K091243 (d3), K033805 (d3), K051567 (d3), K063049 (d3), K092038 (d3), K040022 (d3), K070946 (d3) — cited as predicate by K201656, K202912

K171285 — cites (transitively): K000684 (d1), K011335 (d1), K082300 (d1), K112560 (d1), K112812 (d1), K131311 (d1), K132876 (d1), K151468 (d1), K033995 (d2), K101056 (d2), K103332 (d2), K091679 (d2), K103778 (d2), K023360 (d2), K023365 (d2), K063875 (d2), K112457 (d2), K062498 (d2), K142906 (d2), K073527 (d3), K033805 (d3), K051567 (d3), K063049 (d3), K092038 (d3), K040022 (d3), K070946 (d3) — cited as predicate by K172008, K180972, K201656

K172008 — cites (transitively): K011815 (d1), K151468 (d1), K152158 (d1), K171285 (d1), K103332 (d2), K142906 (d2), K000684 (d2), K011335 (d2), K082300 (d2), K112560 (d2), K112812 (d2), K131311 (d2), K132876 (d2), K033805 (d3), K051567 (d3), K063049 (d3), K092038 (d3), K033995 (d3), K101056 (d3), K091679 (d3), K103778 (d3), K023360 (d3), K023365 (d3), K063875 (d3), K112457 (d3), K062498 (d3), K040022 (d3), K070946 (d3), K073527 (d4) — cited as predicate by K201656, K202912, K230938

K180972 — cites (transitively): K112111 (d1), K130116 (d1), K170705 (d1), K171285 (d1), K012655 (d2), K052776 (d2), K061665 (d2), K063778 (d2), K082095 (d2), K090047 (d2), K092247 (d2), K102694 (d2), K112812 (d2), K131311 (d2), K132876 (d2), K151468 (d2), K000684 (d2), K011335 (d2), K082300 (d2), K112560 (d2), K012694 (d3), K083694 (d3), K092556 (d3), K033995 (d3), K101056 (d3), K103332 (d3), K091679 (d3), K103778 (d3), K023360 (d3), K023365 (d3), K063875 (d3), K112457 (d3), K062498 (d3), K142906 (d3), K073527 (d4), K033805 (d4), K051567 (d4), K063049 (d4), K092038 (d4), K040022 (d4), K070946 (d4) — cited as predicate by K191972, K231251

K193616 — cites (transitively): K152158 (d1)

K201656 — cites (transitively): K063049 (d1), K090053 (d1), K103332 (d1), K112560 (d1), K170313 (d1), K170705 (d1), K171285 (d1), K172008 (d1), K033805 (d2), K051567 (d2), K092038 (d2), K033995 (d2), K101056 (d2), K013248 (d2), K103705 (d2), K112812 (d2), K131311 (d2), K132876 (d2), K151468 (d2), K163044 (d2), K090047 (d2), K092247 (d2), K102694 (d2), K000684 (d2), K011335 (d2), K082300 (d2), K011815 (d2), K152158 (d2), K073527 (d3), K012694 (d3), K083694 (d3), K092556 (d3), K001941 (d3), K043185 (d3), K052614 (d3), K062863 (d3), K102343 (d3), K091679 (d3), K103778 (d3), K023360 (d3), K023365 (d3), K063875 (d3), K112457 (d3), K062498 (d3), K142906 (d3), K073460 (d3), K102429 (d3), K131093 (d3), K962823 (d4), K082320 (d4), K091243 (d4), K040022 (d4), K070946 (d4) — cited as predicate by K221920, K231441

K202912 — cites (transitively): K001945 (d1), K170313 (d1), K172008 (d1), K013248 (d2), K103705 (d2), K112812 (d2), K131311 (d2), K132876 (d2), K151468 (d2), K163044 (d2), K011815 (d2), K152158 (d2), K171285 (d2), K001941 (d3), K043185 (d3), K052614 (d3), K062863 (d3), K102343 (d3), K091679 (d3), K103778 (d3), K023360 (d3), K023365 (d3), K063875 (d3), K112457 (d3), K062498 (d3), K103332 (d3), K142906 (d3), K000684 (d3), K073460 (d3), K102429 (d3), K131093 (d3), K011335 (d3), K082300 (d3), K112560 (d3), K962823 (d4), K082320 (d4), K091243 (d4), K033805 (d4), K051567 (d4), K063049 (d4), K092038 (d4), K033995 (d4), K101056 (d4), K040022 (d4), K070946 (d4), K073527 (d5) — cited as predicate by K231887, K232115

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Jeil Medical Corporation

  • OAI 2014-01-23 Jeil Medical Corporation · 14 citations
  • OAI 2014-01-23 Jeil Medical Corporation · 14 citations