510(k) · Cleared
Recalled · Class II · 2020Titanium Low Profile Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 8, 1999 as substantially equivalent to K934765 (Zimmer, Inc., 1994) and 1 other predicate after a 43-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 2 times.
- Decided
- Jul 8, 1999
- Review
- 43 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934765 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK934765 Trilogy Acetabular SystemZimmer, Inc. · 1994 · Recalled
- This deviceK991807 Titanium Low Profile ScrewsBiomet, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934765 | Trilogy Acetabular System | Zimmer, Inc. | 1994 | 16 |
| 0 (this device) | K991807 | Titanium Low Profile Screws | Biomet, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K934765 | Trilogy Acetabular SystemSummary page 1…w Profile Screws are substantially equivalent to acetabular screws depicted with the following competitive acetabular systems: Trilogy Acetabular System — Zimmer 510(k) K934765 Arthopor Acetabular System — Joint Medical Products Corp. 510(k) K955511 Potential Risks: The potential risks associated with th… | 1994 |
| * | K955511 | Arthopor I & II Acetabular Cup/Arthopor II Oblong Acetabular CupSummary page 1…ed with the following competitive acetabular systems: Trilogy Acetabular System — Zimmer 510(k) K934765 Arthopor Acetabular System — Joint Medical Products Corp. 510(k) K955511 Potential Risks: The potential risks associated with this device are the same as other metallic implants. These include, but are… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2020 | Class II | Z-0621-2021 | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Mar 10, 2011 | Not classified | Z-2135-2011 | Mixed-up of materials/components | One lot of 30 mm screws was switched with one lot of 25 mm screws. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 11 other devices also cite its predicate K934765.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
Total hip replacement procedures for:
1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2) Rheumatoid arthritis
3) Correction of functional deformity
4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
5) Revision procedures where other treatments have failed
The devices are single use implants.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991807 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991807: Titanium Low Profile Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991807
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026